Delving into the Latest Updates on Omalizumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-IgE monoclonal antibody E25, Monoclonal antibody E25, Olizumab

+ [18]

Target

IgE

Mechanism

IgE inhibitors(Immunoglobulin E inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesOtorhinolaryngologic Diseases+ [3]

Active Indication

Food HypersensitivityNasal PolypsRhinitis, Allergic, Seasonal+ [7]

Inactive Indication

Acute Tubulointerstitial NephritisAirway ObstructionAnaphylaxis+ [13]

Originator Organization

Novartis Pharma AG

Active Organization

Novartis Pharmaceuticals Australia Pty Ltd.

Genentech, Inc.Novartis Pharmaceuticals KK

+ [6]

Inactive Organization

Novartis Pharma AG

Drug Highest PhaseApproved

First Approval Date

AU (13 Jun 2002),

Allergic asthmaChronic rhinosinusitis with nasal polypsChronic Urticaria

RegulationPriority Review (US), Breakthrough Therapy (US)

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Structure/Sequence

Sequence Code 81670L

Source: *****

Sequence Code 143601H

Source: *****

The goal of this interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC). The main question it aims to answer is whether these skin barrier abnormalities can be reversed by omalizumab.
If there is a comparison group: Researchers will compare non-food allergic participants (who do not receive omalizumab) to see if they experience skin barrier abnormalities.
All food allergic participants will receive 4 months of Omalizumab treatment as well as two Oral Food Challenges. Participants will all undergo skin barrier assessments.

Start Date01 Oct 2024

Sponsor / Collaborator

National Jewish Health, Inc.

[+1]

NCT06437171

/ RecruitingPhase 4IIT

The Use of Exhaled Nitric Oxide as a Predictive Marker of Allergic Reactions to Oral Food Challenge and Clinical Response of Omalizumab Treatment in Subjects With Multiple Food Allergies

This is a Phase IV, open-label, single-center study to evaluate the change in FeNO as a marker of clinical response to OMA in participants with multiple FA.

Start Date03 Jun 2024

Sponsor / Collaborator-

NCT06771934

/ Active, not recruitingNot ApplicableIIT

Efficacy and Safety Evaluation of Omalizumab Combined With Standardized Allergen Specific Immunotherapy in Moderate to Severe Allergic Asthma

The combined treatment of anti-IgE monoclonal antibody and standardized allergen immunotherapy has good efficacy and safety in allergic diseases. However, the efficacy and safety of the combined treatment for allergic asthma in the Chinese population have not been fully elucidated yet.This study is a prospective observational study designed to evaluate the efficacy and safety of omalizumab combined with allergen immunotherapy (AIT) in patients with moderate to severe asthma in the Chinese population.

Start Date01 Jun 2024

Sponsor / Collaborator

Qianfoshan Hospital of Shandong Province

100 Clinical Results associated with Omalizumab

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100 Translational Medicine associated with Omalizumab

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100 Patents (Medical) associated with Omalizumab

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3,702

Literatures (Medical) associated with Omalizumab

01 Dec 2025·CURRENT ALLERGY AND ASTHMA REPORTS

Olfactory Dysfunction in Chronic Rhinosinusitis with Nasal Polyps: Effect of Treatment with Emphasis on Biological Therapy

Review

Author: Reitsma, Sietze ; Fokkens, Wytske Johanna ; Otten, Josje Janna

PURPOSE OF REVIEW:

Olfactory dysfunction significantly impacts quality of life that affects a majority of the patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The aim of this review is to explore the impact of various treatment regimens on olfactory dysfunction in patients diagnosed with CRSwNP.

RECENT FINDINGS:

Accurate assessment of olfactory dysfunction remains challenging and should incorporate both psychophysical tests and patient-reported outcomes. Patients with CRSwNP appear capable of reliably evaluating their olfactory function. Standard treatment such as intranasal corticosteroids and surgery have limited capability of restoring the sense of smell. Oral corticosteroids have a far greater potency, albeit short-lived and at the cost of adverse events and side effects. Recent studies on registered biological agents- specifically dupilumab, mepolizumab, and omalizumab- indicate their effectiveness in restoring olfactory function in severe CRSwNP. According to meta-analyses and indirect comparisons, dupilumab shows superiority; however, direct comparative studies are necessary.

01 Feb 2025·LARYNGOSCOPE

Impact of Biologics on Surgery in Chronic Rhinosinusitis with Polyps and Allergic Fungal Sinusitis

Article

Author: Bentan, Mihai A. ; Lee, Lawrance ; Schuman, Theodore ; Fitzpatrick, Thomas ; Pingree, Graham

Objective:

To compare the efficacy of th2‐targeted biologic medications (dupilumab, omalizumab, and mepolizumab) on absolute risk reduction (ARR) of functional endoscopic sinus surgery (FESS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) and allergic fungal rhinosinusitis (AFRS).

Methods:

The TriNetX Research Network database was queried for each mAb's market lifespan through March 2024. Adults with CRSwNP were propensity score matched against non‐mAb controls based on age, sex, race, and asthma diagnosis. The primary outcome was rate of FESS, with secondary outcomes including inpatient admission, emergency department (ED) visit, and incidence of acute sinusitis. Subgroup analysis was performed for patients with AFRS.

Results:

All mAbs decreased FESS risk (dupilumab, ARR 11.48%, 95% CI 9.82%–13.15%, p < 0.001; omalizumab, ARR 12.02%, 95% CI 4.36%–19.68%, p = 0.002; mepolizumab, ARR 10.32%, 95% CI 5.24%–15.40%, p < 0.001) in CRSwNP patients. Only dupilumab also reduced risk of inpatient admission (ARR 8.59%, 95% CI 7.04%–10.15%, p < 0.001), ED visit (ARR 5.94%, 95% CI 4.28%–7.61%, p < 0.001), and acute sinusitis (ARR 2.60%, 95% CI 1.09%–4.12%, p = 0.001). In AFRS patients, only dupilumab reduced the risk of all outcomes: FESS (ARR 6.97%, 95 CI 2.86%–11.09%, p = 0.001), inpatient admission (ARR 16.93%, 95% CI 11.30%–22.57%, p < 0.001), ED visit (ARR 13.15%, 95% CI 7.15%–19.14%, p < 0.001), and acute sinusitis (ARR 7.17%, 95% CI 2.18%–12.17%, p = 0.005).

Conclusion:

Although all mAbs reduced FESS risk in CRSwNP, only dupilumab reduced secondary outcomes as well. Similarly, only dupilumab improved all outcomes in AFRS patients. These data demonstrate the potential of mAbs in reducing disease burden and enhancing patient outcomes in CRSwNP and AFRS.

Level of Evidence:

NA Laryngoscope, 135:593–601, 2025

01 Feb 2025·The journal of allergy and clinical immunology. Global

Utility of serum biomarkers in real-world practice for predicting response to omalizumab therapy in patients with chronic spontaneous urticaria

Article

Author: Bernstein, Jonathan A ; Jandarov, Roman A ; Cain, Wesley V ; Priya, Mohana ; Rao, Marepalli

Background:

Omalizumab (OMA), a recombinant humanized IgG monoclonal anti-IgE antibody, is approved for treatment for chronic spontaneous urticaria (CSU) refractory to second-generation H₁-antihistamine (SGAH) therapy. However, currently, there are no validated serum biomarkers to reliably predict response to OMA treatment.

Objective:

We explored the real-world clinical utility of using serum biomarkers for predicting response to OMA for CSU patients with disease refractory to high-dose SGAH therapy.

Methods:

A single-center, retrospective chart review of CSU patients treated with OMA enrolled patients who had at their initial evaluation collection of a basophil histamine release assay for detecting IgG antibodies targeting FcεR1α subunit before starting OMA treatment. In addition, total IgE, IgG-anti-thyroid peroxidase (TPO), C-reactive protein, and absolute eosinophil count, if available, were analyzed as predictors for OMA response. The validated Outcome and Assessment Information Set Database (OASIS-D) rating system was used to assess responsiveness to OMA.

Results:

High levels of IgG-anti-TPO were significantly associated with a poor response to OMA. However, basophil histamine release assay, total IgE, C-reactive protein, and absolute eosinophil count, as well as IgG-anti-TPO/total IgE ratios, were not predictive of a response to OMA therapy.

Conclusions:

This real-world study confirms previous reports that a high IgG-anti-TPO level is a reliable predictor of poor response to OMA. However, better validation of basophil histamine release assay and other immunoassays that measure IgG antibodies to FcεR1α subunit are required before they can be recommended as predictors for OMA response. Whether any of these biomarkers are relevant for predicting response to novel advanced therapeutics under current development requires further investigation.

184

News (Medical) associated with Omalizumab

04 Feb 2025

·www.prnewswire.com

Latitude Food Allergy Care Opens Third New York Clinic to Expand Food Allergy Treatment Access

New clinic is the first and only dedicated food allergy office in Westchester County; Led by Dr. Zoya Treyster RYE BROOK, N.Y., Feb. 4, 2025 /PRNewswire/ -- Latitude Food Allergy Care, the leading network of food allergy clinics in the United States, has opened a new location in Westchester County – its third location in the New York area. As part of the opening, Dr. Zoya Treyster, has joined the Latitude medical staff and will lead the clinical team in Westchester. She brings over 15 years of dedicated allergy and immunology clinical experience to the practice. Food allergies continue to surge in the U.S., yet access to accurate diagnosis and care remains a critical gap in helping children and adults undergo life-changing treatments. In the Westchester County regional area, it is estimated there are more than 16,000 people navigating food allergies. Many patients travel far distances or wait for many months to see food allergy specialists as traditional allergists are not equipped or simply do not have the time to offer treatment to patients. With Latitude, families in New Jersey, Connecticut and New York can easily schedule appointments in either their Westchester, Manhattan or Brooklyn offices, avoiding delays that they're typically accustomed to with traditional care options. "Food allergy care needs to be accessible to all patients. Latitude is committed to expanding our footprint across the U.S., so we can help even more people live without fear, and experience life unburdened by the limitations of food allergies," said Kimberley Yates, co-founder and CEO of Latitude Food Allergy Care. "Our clinics have a proven track record with successful outcomes for thousands of patients — many who are now able to eat and enjoy foods and activities they'd previously been avoiding." Founded in 2018, Latitude was born from the first-hand experiences of its founders' food allergy families and driven by the expertise of board-certified allergists. Now with seven locations, Latitude is giving families the freedom and control they deserve. Each clinic offers comprehensive, accurate testing and treatment tailored to the individual needs and goals of their patients and families – this can include a combination of treatments including oral immunotherapy (OIT), sublingual immunotherapy (SLIT), and Xolair. "As a food allergy mom, I am acutely familiar with how food allergies can impact daily life. When my son was diagnosed with a tree nut allergy, I knew that I needed to start oral immunotherapy as soon as possible. Early intervention is critical for the best outcomes in food allergy. I quickly realized that there was a gap in access to oral immunotherapy locally," said Zoya Treyster, MD, FACAAI, lead allergist at the Westchester office. "I've joined Latitude to address this critical service gap in Westchester. Latitude's treatments can help people like my son overcome the burden of food allergies, and live a life with less restriction and stress." The clinic's temporary location is at 800 Westchester Avenue, Suite N-611, Rye Brook, NY 10573. To book an appointment, email [email protected] or call (914) 898-9575. Appointments are available now. This spring, Latitude will open its permanent office in White Plains. About Latitude Food Allergy Care Latitude Food Allergy Care is the leading network of clinics dedicated to treating food allergies. Led by board-certified allergists, Latitude redefines care through advanced diagnostics, evidence-based approaches such as OIT, and personalized treatment plans. Latitude offers world-class care in-network with most PPO insurance plans and many HMO plans in California and New York. Learn more at latitudefoodallergycare.com and follow Latitude on Instagram, Facebook, and Linkedin. SOURCE Latitude Food Allergy Care WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Immunotherapy

24 Jan 2025

·www.drugs.com

Guidance Developed for Diagnosis, Management of Eosinophilic Esophagitis

FRIDAY, Jan. 24, 2025 -- In a clinical guideline issued by the American College of Gastroenterology and published in the January issue of the American Journal of Gastroenterology , recommendations are presented for the diagnosis and management of eosinophilic esophagitis (EoE). Evan S. Dellon, M.D., M.P.H., from the University of North Carolina School of Medicine in Chapel Hill, and colleagues made recommendations across domains of diagnosis, treatment, monitoring, and assessment of response and pediatric-specific considerations for EoE. The authors recommend that EoE is diagnosed based on the presence of symptoms of esophageal dysfunction and at least 15 eosinophils per high-power field on esophageal biopsy. A systematic endoscopic scoring system is recommended to characterize endoscopic findings of EoE at every endoscopy. To assess for histologic features consistent with EoE, at least six esophageal biopsies from at least two esophageal levels should be obtained. Eosinophil counts should be quantified on esophageal biopsies from every endoscopy performed. Proton pump inhibitors (PPIs) are suggested as a treatment for EoE, while swallowed topical steroids are recommended as a treatment. Use of either fluticasone propionate or budesonide is suggested for patients with EoE treated with topical steroids. An empiric food elimination diet is suggested for EoE treatment, but currently available allergy testing to direct food elimination diets is not suggested. Dupilumab is suggested for individuals aged 12 years or older and for pediatric patients who are nonresponsive to PPI therapy. Omalizumab is not suggested for EoE treatment. For esophageal strictures causing dysphagia, endoscopic dilation is suggested as an adjunct to medical therapy. "For all treatments, cost and insurance coverage should be considered on an individual basis because there are scant cost-effectiveness data to currently support decisions," the authors write. Several authors disclosed ties to the pharmaceutical industry. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

09 Jan 2025

·www.pharmaceutical-technology.com

Palforzia’s peanut allergy treatment use in Europe expanded to toddlers

Around one in 40 infants in the UK are estimated to develop a peanut allergy. Image credit: Shutterstock / Towfiqu ahamed barbhuiya. The European Commission (EC) has approved the extension of Stallergenes Greer’s Palforzia (defatted powder of Arachis hypogaea L., semen (peanut)) for treatment of peanut allergy in patients aged one to three years, permitting earlier treatment for one of the most common food allergies. The extension to the marketing authorisation means paediatric patients aged up to 17 years with a confirmed diagnosis of peanut allergy can use the immunotherapy. It can also be used in adults aged 18 and older when combined with a peanut-avoidant diet. The approval in Europe follows the same extension made by the US Food and Drug Administration (FDA) in July 2024, meaning Palforzia is the only oral immunotherapy approved for peanut allergy-affected toddlers in the two regions. The drug was first approved in Europe and the US in 2020. The EC based its decision on data from the Phase III POSEIDON study (NCT03736447), which met its primary endpoint of the percentage of subjects who could tolerate a high dose of peanuts in a food challenge. Secondary efficacy endpoints were also met. Allergy biopharma company Stallergenes Greer acquired Palforzia from Nestle in September 2023 for an undisclosed amount. Nestle itself had acquired the drug in a $2.1bn buyout of Aimunne Therapeutics, the peanut allergy treatment’s original developer. Nestle’s decision to sell Palforzia stemmed from slow uptake and weak sales. More than 17 million people in Europe are estimated to have a peanut allergy , and it is one of the most common food allergies in children. AllergyUK estimates that one in 40 breast-fed infants develop a peanut allergy. Taken as a powder in capsules or sachets, Palforzia works by gradually increasing the body’s ability to cope with small amounts of peanuts in a process called desensitisation. The drug has been shown to reduce the severity of allergic reactions after peanut exposure, though it does not treat the symptoms of the allergy itself, meaning it should not be taken during an allergic reaction. The extension to toddlers is an important milestone because it means treatment can be initiated at an earlier age. Dr Katharina Blümchen, professor at the University of Medicine of Frankfurt’s paediatric and adolescent medicine clinic, said: “Early intervention is crucial to reduce the risks of accidental exposure and may be very important in improving long-term outcomes. The approval of Palforzia for toddlers represents for the medical community a meaningful advancement in managing allergy at a pivotal stage in a child’s development.” Also in the allergy treatment space is Roche and Novartis’ Xolair (omalizumab), which gained supplemental FDA approval in February 2024. It is the first medicine approved to reduce allergic reactions after accidental exposure to foods. Common foods that trigger allergies such as peanuts, milk, and wheat are covered by the drug.

Drug ApprovalClinical ResultAcquisitionPhase 3Immunotherapy

100 Deals associated with Omalizumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D05251	Omalizumab	R03DX05	DB00043

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Food Hypersensitivity	US	Genentech, Inc.	16 Feb 2024
Nasal Polyps	US	Genentech, Inc.	30 Nov 2020
Rhinitis, Allergic, Seasonal	JP	Novartis Pharmaceuticals KK	11 Dec 2019
Asthma	US	Genentech, Inc.	20 Jun 2003
Allergic asthma	AU	Novartis Pharmaceuticals Australia Pty Ltd.	13 Jun 2002
Chronic rhinosinusitis with nasal polyps	AU	Novartis Pharmaceuticals Australia Pty Ltd.	13 Jun 2002
Chronic Urticaria	AU	Novartis Pharmaceuticals Australia Pty Ltd.	13 Jun 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic sinusitis	NDA/BLA	CN	Beijing Novartis Pharma Co. Ltd.	19 Jul 2022
Chronic sinusitis	NDA/BLA	CN	Novartis Europharm Ltd.	19 Jul 2022
Peanut Hypersensitivity	Phase 3	US	Genentech, Inc.	22 Jul 2019
Peanut Hypersensitivity	Phase 3	US	Novartis Pharmaceuticals Corp.	22 Jul 2019
Bronchitis	Phase 3	CA	Novartis AG	01 Mar 2014
Angioedema	Phase 3	DE	Novartis Pharmaceuticals Corp.	23 Jan 2013
Seasonal allergic conjunctivitis	Phase 3	DE	Novartis Pharmaceuticals Corp.	01 Feb 2006
Persistent asthma	Phase 3	-	Genentech, Inc.	01 Jul 2000
Infertility, Female	Phase 2	DK	Novartis AG	01 Jan 2019
Acute Tubulointerstitial Nephritis	Phase 2	US	Genentech, Inc.	01 Jun 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06316414 (Pubmed \| Allergy)	Not Applicable	Severe asthma total IgE levels	65	Omalizumab	fcrkhfzzct(hctxjtboon) = kwkajbbocu ctkvvoxvxh (zcmxqpwedf ) View more	Positive	16 Sep 2024
				Placebo	fcrkhfzzct(hctxjtboon) = ozmysempgj ctkvvoxvxh (zcmxqpwedf ) View more
NCT01287117 \| NCT01292473 (ASTERIA I and ASTERIA II, Pubmed \| World Allergy Organ J)	Phase 3	Chronic Urticaria	-	Omalizumab 300 mg	rqkxyxnjfd(nximsbabmt) = hisxtbsqzk thognxfvwj (njyuqccsea )	Positive	01 Aug 2024
				Omalizumab 150 mg	rqkxyxnjfd(nximsbabmt) = vvegnchuhd thognxfvwj (njyuqccsea )
AAAAI2024	Not Applicable	Food Hypersensitivity Maintenance IgE antibody	533	Omalizumab	immdxqketq(nxwjcgadwl) = lxpdcmjfxw mrpzsnryak (fjgnnzodeq ) View more	Positive	23 Feb 2024
AAAAI2024	Not Applicable	Chronic Urticaria total serum IgE \| hypothyroidism \| anti-TPO antibodies ... View more	94	Omalizumab 300 mg/month	gyszkerjwb(dujmxzapoh) = fydocmhjmy gnnciuvzjq (nlhpzmmaow )	Positive	23 Feb 2024
				Omalizumab >300 mg/month	gyszkerjwb(dujmxzapoh) = vbjbqrneqs gnnciuvzjq (nlhpzmmaow )
NCT03881696 (OUtMATCH, FDA) Manual	Phase 3	Food Hypersensitivity	165	XOLAIR	faghdcwzkm(sdvldevlrl) = mxxupwrnzl xiiacwrreq (pnvjtcwwli ) View more	Positive	16 Feb 2024
				Placebo	faghdcwzkm(sdvldevlrl) = wehypasavd xiiacwrreq (pnvjtcwwli ) View more
NCT03881696 (OUtMATCH, GlobeNewswire) Manual	Phase 3	Food Hypersensitivity	165	Xolair	xctkxgpdtp(paegjaaota) = These interim results showed that, compared to placebo, Xolair significantly increased the amount of peanut (primary endpoint) and milk, egg and cashew (key secondary endpoints) mnbhmeapgz (tvyymwbqks ) View more	Positive	19 Dec 2023
				placebo
EADV2023	Not Applicable	Chronic Urticaria	57	Omalizumab de-intensified regimen	wpztcczijt(oksgmdxugy) = spwtryrocp mddxddiyim (xzbtjrnbpm ) View more	Positive	11 Oct 2023
				Omalizumab discontinuation	mznacegzuz(notgrcvleo) = yafiptjycr lmjdtevqjh (bcnfrtroxa ) View more
EADV2023	Not Applicable	Chronic Urticaria	93	Omalizumab	qqmghzbauq(wwavmhnejs) = tmktwqgvxs blgtuogdwl (cfrxglsyyn )	-	11 Oct 2023
EADV2023	Not Applicable	Pemphigoid, Bullous IgE levels	36	Omalizumab 300 mg	crcwhdckrw(lppaqsmhxd) = ogiifxxfqf locmbvfqqf (czqhjqfjet )	Positive	11 Oct 2023
WCD2023	Not Applicable	Sunburn	100	Omalizumab	hqmbfyckxl(sthmxusgln) = Periorbital edema, short term asthenia, mild local site reaction and gastrointestinal intolerance were the adverse events reported across 4% of patients kfjiirfnez (dghktywglj )	Positive	07 Jul 2023