This post-marketing study is a multicenter cohort study in individuals aged 60 years or older vaccinated with Abrysvo (RSV vaccine）designed to confirm the safety in individuals aged 60 years or older under actual clinical practice in Japan.

Start Date27 Dec 2024

Sponsor / Collaborator

Pfizer Inc.

NCT06684743

/ RecruitingPhase 4IIT

A Pragmatic Randomized Trial to Evaluate the Vaccine Effectiveness of Abrysvo® for Preventing RSV Hospitalizations in Adults Aged 60 Years or Above

The purpose of this pragmatic randomized trial is to evaluate the vaccine effectiveness of bivalent RSV prefusion F vaccine (RSV vaccine) in older adults. Participants will be randomized 1:1 to either RSV vaccine or no RSV vaccine.

Start Date18 Nov 2024

Sponsor / Collaborator

Herlev and Gentofte Hospital

[+1]

NCT06593587

/ RecruitingPhase 3

A PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN OLDER ADULTS IN KOREA

The goal of this clinical trial is to quantify the immune response in older Korean adults after a RSVpreF vaccination. It will also learn about the safety and tolerability of RSVpreF vaccination. The main questions it aims to answer are:
What local reactions and systemic events do participants have after a RSVpreF vaccination? What medical problems do participants have after a RSVpreF vaccination? Researchers will compare RSVpreF to a placebo (a look-alike substance that contains no RSVpreF) to see if RSVpreF is safe and well tolerated. It will also examine the change in antibody levels (immune responses) before and after vaccination.
Participants will:
Receive the RSVpreF vaccination or a placebo injection once at Visit 1. Visit the clinic a month later for a checkup and tests. Receive a phone call 1 week after vaccination, and 2 months after vaccination, for health checks.
Keep a diary of their symptoms for 7 days after vaccination.

Start Date07 Oct 2024

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with RSVpreF

100 Translational Medicine associated with RSVpreF

100 Patents (Medical) associated with RSVpreF

113

Literatures (Medical) associated with RSVpreF

31 Dec 2025·Expert Review of Vaccines

Cost-effectiveness of bivalent respiratory syncytial virus prefusion F vaccine for prevention of respiratory syncytial virus among older adults in Germany

Article

Author: Lade, Caroline ; Averin, Ahuva ; Huebbe, Bennet ; Sato, Reiko ; von Eiff, Christof ; Atwood, Mark ; Bayer, Lea J

INTRODUCTION:

Among older adults, lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) is common. We evaluated the cost-effectiveness of bivalent RSV prefusion F protein-based vaccine (RSVpreF) for prevention of RSV-LRTI among older adults in Germany.

RESEARCH DESIGN AND METHODS:

A static cohort model was developed to estimate lifetime health and economic outcomes of RSV-LRTI among adults aged 60-99 years in Germany, with (vs. without) use of RSVpreF. Vaccine uptake ranged from 27% to 54%. Vaccine effectiveness was derived from trial data and was assumed to last over 3 years, with some waning, following vaccination. Base case analyses were conducted from the societal perspective (costs/benefits discounted 3% annually); sensitivity analyses also were conducted.

RESULTS:

Among adults aged 60-99 years (N = 25.3 M), RSVpreF prevented 117,360 cases of hospitalized RSV-LRTI, 100,433 cases of ambulatory RSV-LRTI, and 9,298 RSV-LRTI-related deaths over a lifetime horizon. With total overall costs higher by 1.8 € billion and 49,576 quality-adjusted life-years (QALYs) gained, cost-effectiveness of RSVpreF was 36,064 €/QALY. In probabilistic sensitivity analyses, the mean cost-effectiveness ratio was 36,518 €/QALY; 925 of 1,000 replications yielded ratios <50,000 €/QALY.

CONCLUSIONS:

RSVpreF has the potential to greatly reduce the public health and economic burden of RSV among older adults in Germany.

01 Feb 2025·OBSTETRICS AND GYNECOLOGY

Efficacy, Safety, and Immunogenicity of the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Respiratory Syncytial Virus Prefusion F Protein Vaccine Trial

Article

Author: Simões, Eric A F ; Li, Weiqiang ; Koury, Kenneth ; Polack, Fernando P ; Van Houten, Marlies A ; Baber, James ; Pahud, Barbara A ; Richmond, Peter C ; Gullam, Joanna ; Stein, Renato T ; Adam, Tyler ; Radley, David ; Huang, Li-Min ; Madhi, Shabir A ; Gurtman, Alejandra ; Staerke, Nina B ; Kampmann, Beate ; Tapiero, Bruce ; Lino, Maria Maddalena ; Bont, Louis J ; Barnabas, Shaun L ; Llapur, Conrado ; Vargas, Sergio L ; Swanson, Kena A ; Perreras, Nicole ; Fausett, Merlin ; Munjal, Iona ; Kantele, Anu ; Zar, Heather J ; Anderson, Annaliesa S ; Otsuki, Takeo ; Cooper, David ; Sarwar, Uzma N ; Shittu, Emma ; Kalinina, Elena V ; Padilla, María Duron ; Pérez Marc, Gonzalo ; Baker, Jeffrey

OBJECTIVE::

To evaluate descriptive efficacy data, exploratory immunogenicity data, and safety follow-up through study completion from the global, phase 3 MATISSE (Maternal Immunization Study for Safety and Efficacy) maternal vaccination trial of bivalent respiratory syncytial virus (RSV) prefusion F protein vaccine (RSVpreF).

METHODS::

MATISSE was a phase 3, randomized, double-blinded, placebo-controlled trial. Healthy pregnant participants aged 49 years or younger at 24–36 weeks of gestation were randomized (1:1) to receive a single RSVpreF 120 micrograms or placebo dose. Primary efficacy endpoints included newborn and infant severe RSV-associated medically attended lower respiratory tract illness within 180 days after birth. The RSV-A and RSV-B serum neutralizing antibody titers were determined in a subset of pregnant participants and their newborns.

RESULTS::

In this final analysis, 7,420 pregnant participants were randomized, and 7,307 children were born (RSVpreF n=3,660, placebo n=3,647). Vaccine efficacy, defined as protection against newborn and infant severe RSV-associated medically attended lower respiratory tract illness, was 82.4% (95% CI, 57.5–93.9) and 70.0% (95% CI, 50.6–82.5) within 90 and 180 days of birth, respectively. The RSVpreF induced robust immune responses in pregnant participants and resulted in highly efficient transfer of maternal antibodies to their newborns across subgroups (by gestational age at delivery and at vaccination, number of days from vaccination to delivery, country, maternal age). Final RSVpreF safety results in pregnant and newborn and infant participants were consistent with the primary analysis with no new safety concerns identified.

CONCLUSION::

This final analysis of MATISSE trial data confirms the primary analysis conclusions: Maternal vaccination with RSVpreF has a favorable safety profile in both pregnant and newborn and infant participants and demonstrates efficacy against RSV-associated lower respiratory tract illness in infants through age 6 months. The RSVpreF induces robust immune responses in pregnant individuals, with corresponding high RSV-neutralizing titers in their newborns.

CLINICAL TRIAL REGISTRATION::

ClinicalTrials.gov, NCT04424316.

01 Feb 2025·OBSTETRICS AND GYNECOLOGY

Preterm Birth Frequency and Associated Outcomes From the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Trial of the Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine

Article

Author: Llapur, Conrado ; Simões, Eric A F ; Maldonado, Yvonne ; Swanson, Kena A ; Pahud, Barbara A ; Munjal, Iona ; Pérez Marc, Gonzalo ; Zar, Heather J ; Sarwar, Uzma N ; Shittu, Emma ; Radley, David ; Anderson, Annaliesa S ; Zachariah, Philip ; Gurtman, Alejandra ; Madhi, Shabir A ; Lino, Maria Maddalena ; Kampmann, Beate ; Kachikis, Alisa

OBJECTIVE::

To describe preterm birth frequency and newborn and infant outcomes overall and among preterm children in the MATISSE (Maternal Immunization Study for Safety and Efficacy) trial of maternal vaccination with bivalent respiratory syncytial virus (RSV) prefusion F protein–based vaccine (RSVpreF) to protect infants against severe RSV-associated illness.

METHODS::

MATISSE was a global, phase 3, randomized, double-blind trial. Pregnant individuals received single injections of RSVpreF or placebo. Adverse events of special interest, including preterm birth (gestational age less than 37 weeks) and low birth weight (2,500 g or less), were collected through 6 months after delivery (pregnant participants) and from birth through age 12 or 24 months (pediatric participants).

RESULTS::

Overall, 7,386 pregnant participants received RSVpreF (n=3,698) or placebo (n=3,688); 7,305 newborns and infants were included in the analysis. Most children in both groups were born full term (more than 93%) with normal birth weight (95% or higher). Newborn and infant outcomes, including rates of low birth weight and neonatal hospitalization, were favorable and comparable between groups. Preterm birth rates were 5.7% in the RSVpreF arm and 4.7% in the placebo arm (relative risk [RR] 1.20, 95% CI, 0.98–1.46); most were late preterm. Newborn and infant outcomes, including rates of low birth weight and neonatal hospitalization, were comparable between groups. Twenty-two newborn or infant deaths occurred during the study (RSVpreF n=8, placebo n=14). When stratified by income region, preterm birth rates in RSVpreF and placebo recipients were both 5.0% in high-income countries. Rates in non–high-income countries were 7.0% and 4.0% in the RSVpreF and placebo groups, respectively, and 8.3% and 4.0% in South Africa (RR 2.06, 95% CI, 1.21–3.51).

CONCLUSION::

In this study of maternal RSVpreF vaccination, no clinically significant increase in adverse events of special interest, including preterm birth, low birth weight, or neonatal hospitalization, was observed among pregnant people in the overall analysis. In subgroup analysis of non–high-income countries, an elevated risk of preterm birth was observed. More research is needed to better ascertain preterm delivery risk factors, particularly aimed at minimizing disparities among geographic regions.

FUNDING SOURCE::

This study was sponsored by Pfizer.

CLINICAL TRIAL REGISTRATION::

ClinicalTrials.gov, NCT04424316.

207

News (Medical) associated with RSVpreF

13 Jan 2025

·www.drugs.com

FDA Adds Warning Label to RSV Vaccines Abrysvo and Arexvy

MONDAY, Jan. 13, 2025 -- The U.S. Food and Drug Administration now requires and has approved safety labeling changes to the prescribing information for the Abrysvo (Pfizer) and Arexvy (GlaxoSmithKline) respiratory syncytial virus (RSV) vaccines to include warnings and precautions about the risk for Guillain-Barré syndrome (GBS). For each vaccine, postmarketing observational studies suggest an increased risk of GBS during the 42 days following vaccination. Arexvy has been approved for the prevention of lower respiratory tract disease caused by RSV in all individuals 60 years of age and older and for those aged 50 to 59 years at increased risk. Abrysvo has been approved for the prevention of lower respiratory tract disease caused by RSV in all individuals 60 years of age and older, as well as individuals aged 18 to 59 years at increased risk. Abrysvo is also approved for pregnant individuals at 32 through 36 weeks of gestational age for the prevention of lower respiratory tract disease caused by RSV in infants from birth through 6 months of age. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Drug ApprovalVaccineClinical Study

08 Jan 2025

·endpts.com

Pfizer, GSK add risk of Guillain-Barré to RSV vaccine labels at FDA's request

Pfizer and GSK’s RSV vaccines have a new warning at the request of the FDA, relaying an increased risk of Guillain-Barré syndrome within the first 42 days post-vaccination. The agency said in a bulletin Tuesday that “the overall body of evidence suggests increased risks of GBS with Abrysvo and Arexvy, but that available evidence is insufficient to establish a causal relationship.” The FDA approved updated labels for both companies on Monday. The neurological autoimmune condition is marked by tingling or weakness in people’s arms and legs, and sometimes arise within weeks after an infection. GSK said in a statement that it has its own ongoing safety studies, including on the risk of GBS, but that it remains “confident in the benefit-risk profile of Arexvy for the prevention of RSV-LRTD.” Pfizer reiterated the FDA’s conclusion in a statement. Key data underpinning the decision came from an FDA post-marketing study assessing the risk of GBS across the two vaccines, finding there were nine excess cases of the condition per million doses administered of Pfizer’s Abrysvo, and seven excess cases per million doses administered of GSK’s Arexvy to adults 65 and older. The FDA previously presented the study findings at the CDC’s Advisory Committee on Immunization Practices in October, which showed a statistically significant risk increase for GSK’s vaccine but not Pfizer’s, given that it had fewer doses administered in the study. Still, the agency concluded then that Pfizer’s shot came with an elevated risk. FDA presenters concluded then that the risk of GBS post-vaccination of either shot remained “rare” and that the risks didn’t deviate based on whether people received other vaccines at the same time. An FDA reviewer told the CDC panel that it could not break down the risk by age based on the sample size of the post-marketing study. Moderna, which had its RSV vaccine approved after the post-marketing study began, was not included in the FDA’s label change. At the time of ACIP’s October meeting, no cases of GBS had been found within 42 days of vaccination in Moderna’s clinical trials and post-licensure surveillance data wasn’t yet available. Other vaccines have had varying risks associated with GBS, including the flu vaccines which have a small, one-to-two-case risk increase per million doses of flu vaccine administered. For Johnson & Johnson’s one-shot Covid-19 vaccine, the GBS risk was 11 times higher within the first 42 days than the Pfizer or Moderna options. The label warning follows a bleak second vaccination season for RSV makers, marked by tightened guidance, significantly less uptake and now a safety warning. Prescription data through the middle of December found that uptake was roughly 50% less than through the same period in 2023, according to Jefferies research.

VaccinemRNAClinical Study

08 Jan 2025

·www.prnewswire.com

Clarivate Identifies Eleven Potential Blockbuster and Transformative Drugs in Annual Drugs to Watch Report

Anticipated advancements in obesity, oncology, gene therapy and other areas poised to revolutionize patient care LONDON, Jan. 8, 2025 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT) a leading global provider of transformative intelligence, today announced the release of the twelfth annual Drugs to Watch™ report, a trusted guide to the therapies poised to redefine the future of healthcare. This year, the highly anticipated resource highlights 11 drugs projected to achieve blockbuster status or revolutionize treatment paradigms within five years. Since its inception, Drugs to Watch has identified over 98 transformative therapies, cementing its role as an essential resource for navigating the ever-evolving pharmaceutical landscape. This year's report, powered by insights from the Clarivate Cortellis intelligence suite of products, highlights 11 therapies that have recently launched or are set to debut in 2025. These innovations, addressing critical challenges in areas such as obesity, oncology, and gene therapy, are forecast to achieve blockbuster sales by 2030 or dramatically improve patient outcomes on a global scale. The report also explores pivotal trends shaping the industry, including the surging demand for obesity treatments, the transformative potential of gene editing, and the growing impact of regulatory innovation. The report offers an in-depth analysis of the chronic disease market in Mainland China, spotlighting five therapies expected to exceed $1 billion in annual sales over the next five years or deliver transformative outcomes for patients. It also explores critical topics shaping global healthcare, including regulatory advancements, the role of radiopharmaceutical theranostics in oncology, and the growing use of real-world data (RWD) and patient-reported outcomes (PROs) to drive health equity and enhance regulatory submissions. Henry Levy, President, Life Sciences & Healthcare, Clarivate, remarked: "Innovation in the life sciences is reaching unprecedented heights, and this year's Drugs to Watch™ report once again demonstrates the industry's ability to deliver therapies that address unmet medical needs and challenge existing paradigms of care. At Clarivate, we take pride in the precision and reliability of our predictions—last year, we identified 13 molecules as Drugs to Watch, with 12 already approved and launched and one poised for launch. This track record reflects the strength of our comprehensive data and deep expertise. By continuing to provide actionable insights, we empower the sector to navigate opportunities, overcome challenges and drive progress in advancing global health." Mike Ward, Global Head of Thought Leadership, Life Sciences & Healthcare, Clarivate, stated: "2025 represents a turning point for the life sciences sector as it embraces cutting-edge technologies such as AI and machine learning to enhance drug discovery and development. This year's report captures the dynamic forces at play, including groundbreaking progress in precision oncology, the rise of radiopharmaceuticals, and the growing focus on addressing global health disparities." The 2025 Drugs to Watch™ report highlights key trends reshaping the life sciences landscape, emphasizing the transformative impact of emerging technologies and therapeutic breakthroughs. Advances in AI and machine learning are streamlining drug discovery, clinical trials, and real-world data integration, enabling precision medicine approaches. The obesity market is undergoing a revolution driven by next-generation GLP-1 therapies, while radiopharmaceutical theranostics are redefining cancer treatment with a "see it and treat it" paradigm. Gene editing technologies are unlocking new opportunities in personalized medicine, and evolving regulatory frameworks are fostering greater emphasis on patient-reported outcomes and health equity. Together, these trends showcase the sector's resilience and its ability to navigate challenges while driving innovation to improve patient care worldwide. This year's drugs to watch exemplify the fusion of innovation and dedication to advancing patient care in an increasingly complex healthcare ecosystem. The Drugs to Watch™ 2025 list include: AWIQLI® (LAI 287; insulin icodec) developed by Novo Nordisk | Type 1 and type 2 diabetes mellitus AWIQLI®, the first once-weekly, subcutaneous insulin, has launched in Australia, Canada, the EU, Mainland China, and Japan. Its weekly dosing offers a significant advantage over daily basal insulin, potentially reducing the treatment burden for patients with type 1 or type 2 diabetes (T1DM and T2DM). CagriSema (cagrilintide + semaglutide) developed by Novo Nordisk | Obesity and type 2 diabetes mellitus CagriSema, combining cagrilintide, a long-acting amylin analog, with semaglutide, promises superior efficacy over semaglutide (OZEMPIC/WEGOVY®) and tirzepatide (MOUNJARO/ZEPBOUND®) in treating obesity and type 2 diabetes. This next-generation GLP-1 therapy leverages the benefits of GLP-1s, such as enhanced insulin secretion and appetite reduction, while incorporating amylin's effects, including slowed glucose absorption and release. If approved, CagriSema will be the first fixed-dose combination of amylin and GLP-1 receptor agonists in the obesity and T2DM markets. COBENFY™ (KarXT; xanomeline-trospium) developed by Bristol Myers Squibb | Schizophrenia and psychosis related to Alzheimer's disease Amid setbacks for emerging schizophrenia treatments, the approval of COBENFY marks a transformative milestone as the first drug in over 30 years with a novel mechanism of action for treating schizophrenia. Combining xanomeline and trospium, COBENFY selectively targets M1 and M4 receptors, rather than traditional dopamine pathways, while minimizing cholinergic side effects. While further data is needed to assess its effectiveness in Alzheimer's disease-related psychosis, COBENFY shows strong commercial potential if proven effective in treating AD-related hallucinations and delusions. EBGLYSS™ (lebrikizumab) developed by Eli Lilly and Co and Almirall | Atopic dermatitis EBGLYSS™, the third biologic targeting IL-13 for atopic dermatitis, follows DUPIXENT® (dupilumab) and ADBRY®/ADTRALZA® (tralokinumab) to market. Its less frequent dosing, more selective IL-13 inhibition, and strong efficacy and safety data position it as a likely first-line treatment for moderate-to-severe atopic dermatitis when topical corticosteroids are inadequate. Fitusiran developed by Alnylam® Pharmaceuticals Inc and Sanofi | Hemophilia A and B Fitusiran, shown to be effective in phase 3 trials for both hemophilia A and B, regardless of inhibitor status, has the potential to offer a new approach to hemophilia treatment. This small interfering RNA (siRNA) therapy works by inhibiting SerpinPC1 mRNA, reducing antithrombin levels, promoting thrombin generation, and helping to rebalance hemostasis to prevent bleeds. Leveraging Alnylam® Pharmaceuticals' ESC-GalNAc conjugate technology, fitusiran could become the first antithrombin-lowering therapy based on a double-stranded RNA molecule, pending approval. GSK-3536819 (MenABCWY) developed by GSK plc | Meningococcus GSK plc's GSK-3536819 vaccine candidate, a 5-in-1, first-generation formulation, targets the five groups of Neisseria meningitidis (A, B, C, W, and Y) responsible for most invasive meningococcal disease (IMD) cases worldwide. It combines the antigenic components of GSK's licensed meningococcal vaccines, BEXSERO (MenB) and MENVEO (MenACWY), both of which have established efficacy and safety profiles. IMDELLTRA™ (tarlatamab-dlle) developed by Amgen | Small-cell lung cancer (SCLC) IMDELLTRA™ is a first-in-class immunotherapy for extensive-stage small cell lung cancer (ES-SCLC). Using Amgen's bispecific T cell engager (BiTE®) molecules, it targets CD3 on T cells and DLL3 on tumor cells, enabling T cells to attack and lyse the tumor. DLL3 is expressed on the surface of SCLC cells in more than 85% of patients but is minimally expressed on healthy cells making it an attractive target. This mechanism positions IMDELLTRA as a potential standard of care for previously treated ES-SCLC. mRESVIA (mRNA-1345) developed by Moderna Inc | RSV With its U.S. FDA approval in May 2024, mRESVIA® joined AREXVY and ABRYSVO, both featured in Drugs to Watch 2024, as respiratory syncytial virus (RSV) vaccines currently available for adults ages 60 years and older, helping further support the public health initiative to reduce the RSV-related disease burden. Even with available vaccines, RSV infections continue to be a public health concern, particularly for infants and older adults (65 years and older). SEL-212 developed by Sobi® and Cartesian Therapeutics Inc/Selecta Biosciences Inc | Gout SEL-212 is a novel, once-monthly treatment combining pegylated uricase (pegadricase; SEL-037) with ImmTOR™, an immune tolerance technology designed to inhibit the formation of anti-drug antibodies (ADAs). For this application, ImmTOR consists of SEL-110.36, an inhibitor of uricase-specific ADA. This approach may help overcome the limitations of reduced efficacy and tolerability seen with other biologic treatments, such as KRYSTEXXA® (pegloticase), in patients with chronic gout. Vepdegestrant (ARV-471) developed by Arvinas Inc and Pfizer Inc | Breast cancer A global collaboration between Arvinas Inc and Pfizer Inc, vepdegestrant may become the first PROteolysis Targeting Chimera (PROTAC®) protein degrader on the market. Designed to target and degrade the estrogen receptor (ER) protein, early studies suggest PROTAC-induced degradation is more complete than with oral selective estrogen receptor degraders (SERDs). This offers potential for overcoming endocrine resistance in breast cancer. Label expansions, including combination with IBRANCE® (palbociclib), are being explored. Zanzalintinib (XL092) developed by Exelixis Inc | Colorectal cancer, renal cell carcinoma and squamous cell carcinoma of head and neck Zanzalintinib is a third-generation oral tyrosine kinase inhibitor targeting VEGF receptors, MET, and TAM kinases involved in tumor growth and immunosuppression. Currently in phase 3 trials for non-clear-cell renal cell carcinoma (nccRCC), colorectal cancer (CRC) and squamous cell carcinoma of the head and neck (SCCHN), the company anticipates one potential zanzalintinib launch per year starting as early as 2026. Compared to CABOMETYX® (cabozantinib), zanzalintinib may offer benefits, including approval for nccRCC histology and a broader patient population. Access the Drugs to Watch 2025 report from Clarivate, here. For more Drugs to Watch updates and analyses throughout the year, visit the Drugs to Watch web page and follow Clarivate for Life Sciences & Healthcare on LinkedIn and X. Join the conversation, using #DrugstoWatch. To learn more about how Clarivate can help healthcare companies inform and shape the drug discovery, development and delivery process, visit here. Methodology for the Clarivate Drugs to Watch 2025 Report To identify this year's Drugs to Watch, Clarivate drew from the expertise of over 160 analysts covering hundreds of diseases, drugs and markets, along with 11 integrated data sets that span the R&D and commercialization lifecycle, including: Cortellis Competitive Intelligence™, Disease Landscape & Forecast, Epidemiology Intelligence, BioWorld™, Cortellis Regulatory Intelligence™, Drug Timeline & Success Rates, Cortellis Clinical Trials Intelligence™, Cortellis Deals Intelligence™, Access & Reimbursement payer studies, Clarivate Real-World Data and Analytics, Web of Science™, Derwent Innovation™, and other industry sources including biopharma company press releases, filings and peer-reviewed publications. Candidate drugs in phase 2 or phase 3 trials, at pre-registration or registration stage, or already launched in 2024 were selected for analysis, including both novel treatments and already-marketed drugs pursuing new indications that could be particularly impactful. Drugs launched prior to 2024 were excluded. The dataset was filtered for drugs that had total forecast sales of $1 billion or more by 2030. Clarivate experts and analysts evaluated each drug in its individual context, based on factors such as expected approval or launch dates, competitive landscape, regulatory status, trial results, market dynamics and other key factors, and added novel drugs that, while likely to fall short of blockbuster status, are poised to be therapeutic game-changers. Please note that Clarivate analysts generated the data shown in this report prior to December 31, 2024. The Drugs to Watch 2025 Report and the treatments referenced in this release are based on Clarivate's current expectations per existing data, but actual results derived from the drugs named in the report and here may differ significantly. Clarivate is committed to comprehensively supporting customers across the entire drug, device and medical technology lifecycles to advance human health. By combining patient journey data, therapeutic area expertise, artificial intelligence and analytics in ways that unlock hidden insights, data-driven decisions and accelerating innovation, Clarivate's end-to-end research intelligence is designed to enable customers to make informed evidence-based decisions. About Clarivate Clarivate™ is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit . Media Contact: Catherine Daniel Director, External Communications, Life Sciences & Healthcare [email protected] SOURCE Clarivate Plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

VaccinePhase 3Immunotherapy

100 Deals associated with RSVpreF

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pneumonia due to respiratory syncytial virus	EU	Pfizer Europe MA EEIG	23 Aug 2023
Pneumonia due to respiratory syncytial virus	IS	Pfizer Europe MA EEIG	23 Aug 2023
Pneumonia due to respiratory syncytial virus	LI	Pfizer Europe MA EEIG	23 Aug 2023
Pneumonia due to respiratory syncytial virus	NO	Pfizer Europe MA EEIG	23 Aug 2023
Respiratory Syncytial Virus Infections	US	Pfizer Inc.	31 May 2023
Lower Respiratory Tract Infections	CA	Pfizer Canada ULC	04 Jan 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 3	AU	Pfizer Inc.	13 Apr 2022
Respiratory Tract Infections	Phase 3	US	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	JP	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	AR	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	AU	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	BR	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	CA	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	CL	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	DK	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	FI	Pfizer Inc.	17 Jun 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05886777 (CTgov)	Phase 2	COVID-19 \| Infectious Lung Disorder	1,142	QIV+RSVpreF (Group 1: [RSVpreF + BNT162b2] + QIV)	dahwwcccdz(ldkemriapw) = zmpsjxlypg lwrewvwwnm (hyyusqflvo, kkkcbftbqy - edjegmmibc) View more	-	18 Dec 2024
				Placebo+BNT162b2+RSVpreF (Group 2: [RSVpreF+BNT162b2] + Placebo)	dahwwcccdz(ldkemriapw) = wrmlwzaeni lwrewvwwnm (hyyusqflvo, tidguuudng - mjchkrydaz) View more
NCT05788237 (CTgov)	Phase 1	Influenza, Human	508	RSVpreF+qIRV (SSA: Group 1: RSVpreF + qIRV)	dtczfplbzm(dvoqkgotkk) = zwwnkpzgkk tmfwyvbpir (iusikzbwgl, sirachxayy - pohmclumla) View more	-	22 Nov 2024
				qIRV (SSA: Group 2: qIRV)	dtczfplbzm(dvoqkgotkk) = kchegvtfmu tmfwyvbpir (iusikzbwgl, xiyscxahcf - cyzxusagyp) View more
NCT05842967 (MONeT, PipelineReview) Manual	Phase 3	Respiratory Syncytial Virus Infections	203	ABRYSVO	ejudwfjziu(yaqumrmagw) = ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine. uvvpnhioxb (axcicurvzo ) View more	Positive	12 Aug 2024
NCT04785612 (Phase 2a study, CTgov)	Phase 2	Respiratory Syncytial Virus Infections	70	RSVPreF (RSVPreF)	xgoqdxzykt(pqbebgfrxm) = jzxldaktoo fzzgubijtn (hylbwhmmjn, cdbscdezny - wfkwybdrnz) View more	-	07 Aug 2024
				Placebo (Placebo)	xgoqdxzykt(pqbebgfrxm) = wsxtmxbbzl fzzgubijtn (hylbwhmmjn, xhwbjdxmgq - hwdgyklbha) View more
NCT04424316 (MATISSE, Pubmed)	Phase 3	Respiratory Syncytial Virus Infections	-	RSVpreF vaccine	utgjardanq(okldwsfccy) = mevfxwlvrl okmkkdkbzt (qvkmlyklzn ) View more	Positive	08 Jun 2024
				bivalent RSVpreF maternal vaccination (Placebo)	utgjardanq(okldwsfccy) = wuudyczpxt okmkkdkbzt (qvkmlyklzn ) View more
NCT05842967 (MONeT, Corporate Publications) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive \| Asthma \| Diabetes Mellitus ... View more	-	ABRYSVO	gpptpjgbzx(tzqbueolxv) = Participants demonstrated RSV-A and RSV-B subgroup neutralizing responses non-inferior to the response seen in the Phase 3 (NCT05035212) RENOIR study of ABRYSVO in more than 34,000 adults aged 60 or older where vaccine efficacy was previously demonstrated. otvhjnvowo (aomaeinyfi ) Met View more	Positive	09 Apr 2024
NCT05035212 (RENOIR, Biospace) Manual	Phase 3	Respiratory Syncytial Virus Infections	-	ABRYSVO (three or more symptoms)	qijfardsur(bbuywtcipb) = cesumepetf hiafboivzb (srdaclvslj, 51.4 - 91.1) View more	Positive	29 Mar 2024
				ABRYSVO (two or more symptoms)	qijfardsur(bbuywtcipb) = hoohricsuo hiafboivzb (srdaclvslj, 34.7 - 70.4) View more
NCT05035212 (RENOIR, NEWS) Manual	Not Applicable	Respiratory Syncytial Virus Infections	-	Abrysvo (older adults with two or more symptoms of RSV)	xqmfkeusqj(liwuvsgvnq) = oswakkfygr oaruwwftmu (ouyztcrzhf )	Positive	29 Nov 2023
				Abrysvo (older adults with two or more symptoms)	xqmfkeusqj(liwuvsgvnq) = jhjwtekkod oaruwwftmu (ouyztcrzhf )
NCT04424316 (MATISSE, NEWS) Manual	Not Applicable	Respiratory Syncytial Virus Infections	-	Abrysvo (first 90 days after birth)	lyhkcljdlx(wqzjjbdlex) = qbksxcfiuq ofbohopqni (xxjrnyleas )	Positive	29 Nov 2023
				Abrysvo (within 180 days)	lyhkcljdlx(wqzjjbdlex) = qhxxstqymr ofbohopqni (xxjrnyleas )
NCT05301322 (CTgov)	Phase 3	Respiratory Syncytial Virus Infections \| Influenza, Human	1,471	SIIV+RSVpreF (RSVpreF + SIIV: Coadministration Group)	bxycwjjioz(paurboylmy) = rorazzmxac hfyifypbvp (scpamvzmyg, wkuajgmebo - fgalmeaxdr) View more	-	27 Oct 2023
				Placebo (Placebo: Coadministration Group)	bxycwjjioz(paurboylmy) = irmxwgwsqm hfyifypbvp (scpamvzmyg, hanihkghaf - ueoatzrwvd) View more

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