Chikungunya virus vaccine (Valneva)

The CHMP’s positive opinion is grounded in findings from the STEP HFpEF and STEP HFpEF-DM trials of Wegovy. Credit: S Becker/Shutterstock. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an update to Novo Nordisk ’s Wegovy (semaglutide 2.4 mg) label. This update in the European Union (EU) reflects new data indicating the product’s ability, along with a standard of care, to alleviate symptoms related to heart failure and enhance physical function in individuals with obesity-related heart failure with preserved ejection fraction (HFpEF), irrespective of type 2 diabetes status. The CHMP’s positive opinion is grounded in findings from the STEP HFpEF and STEP HFpEF-DM trials, which involved participants with obesity-related HFpEF. Wegovy showed significant symptom reduction and physical improvements and greater weight loss compared to a placebo in these trials. The trials revealed that the benefits of Wegovy were consistent across demographic and clinical subgroups including age, race, sex, body mass index, ethnicity, region, left ventricular ejection fraction, systolic blood pressure and concurrent heart failure therapy. See Also: Gavi to obtain 500,000 mpox vaccine doses from Bavarian Nordic Valneva eyes teenage label for chikungunya vaccine in Europe and Canada Wegovy recipients experienced a notable improvement in exercise function, measured by the six-minute walking distance (6MWD) over one year, versus placebo. This recommendation to include data from the STEP HFpEF trials complements a recent update to the Wegovy EU label, which incorporated results from the SELECT trial demonstrating the asset’s ability to lower heart attack, stroke and cardiovascular death risk. Novo Nordisk anticipates that the EU label update will take effect soon following the EMA’s linguistic review process. Novo Nordisk Development head and executive vice-president Martin Holst Lange stated: “The recommendation to update the EMA label for Wegovy is an important step forward for people with obesity-related HFpEF who currently have limited treatment options. “Wegovy improves patients’ health-related quality of life, enabling them to live a life with greater functionality to conduct daily activities. These data further add to the body of evidence for the semaglutide molecule.” The latest development comes after Novo Nordisk signed a $600m deal with NanoVation to develop genetic medicines for rare and cardiometabolic diseases.

To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), September 18, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted label extension applications to the European Medicines Agency (EMA) and Health Canada to potentially expand the use of its chikungunya vaccine, IXCHIQ®, to adolescents aged 12 to 17 years in Europe and Canada. The Canadian label extension application also includes two-year antibody persistence data, which is a key differentiator for IXCHIQ® that was already included in the initial EMA filing. Valneva expects to submit data to the U.S. Food and Drug Administration (FDA) this year to also support potential label extensions in the U.S. IXCHIQ® is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. The vaccine is currently approved in the U.S.1, Europe2, and Canada3 for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The U.S. launch is underway while first sales in Canada and Europe are anticipated in the fourth quarter of 2024. In addition to ramping up sales, Valneva is focused on expanding the vaccine’s label and access. The Company expects a marketing authorization in Brazil in the second half of 2024 and recently expanded its partnership with The Coalition for Epidemic Preparedness Innovations (CEPI)4 to support broader access to the vaccine in Low Middle-Income Countries (LMICs), post-marketing trials and potential label extensions in children, adolescents and pregnant women. CEPI will provide Valneva up to $41.3 million of additional funding over the next five years, with support from the European Union’s (EU) Horizon Europe program. Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “Given the substantial risk that chikungunya presents to individuals residing in or traveling to endemic regions, it's imperative to ensure the vaccine is available to all age groups. This broader accessibility would certainly help provide protection and mitigate the burden of this debilitating illness which is currently spreading in areas that were previously unaffected. The durability of the immune response is also extremely important, especially for endemic countries where access to immunization can be difficult." EMA and Health Canada’s label extension applications are based on positive six-month adolescent Phase 3 data which the Company reported in May 20245. These data showed that a single-dose vaccination with IXCHIQ® induces a high and sustained immune response in 99.1% of adolescents, and that the vaccine was generally well tolerated. The Lancet Infectious Diseases, a world leading infectious diseases journal, also recently published an article showing that the vaccine was well tolerated in adolescents aged 12 to 17 years 28 days after a single injection, regardless of previous CHIKV infection. In addition to the adolescent data, Health Canada’s label extension application included IXCHIQ®‘s antibody persistence data which showed that the vaccine’s immune response was sustained for 24 months by 97% of participants and was equally durable in younger and older adults6. The Company expects to publish 36 months persistence data later this year. About ChikungunyaChikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years.7In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas.8 Between 2013 and 2023, more than 3.7 million cases were reported in the Americas9 and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.10 About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines.Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com. Valneva Investor and Media ContactsLaetitia Bachelot-FontaineVP Global Communications & European Investor RelationsM +33 (0)6 4516 7099laetitia.bachelot-fontaine@valneva.com Joshua Drumm, Ph.D.VP Global Investor RelationsM +001 917 815 4520joshua.drumm@valneva.com Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® - Valneva2 Valneva Receives Marketing Authorization in Europe for the World’s First Chikungunya Vaccine, IXCHIQ® - Valneva3 Valneva Announces Health Canada Approval of the World’s First Chikungunya Vaccine, IXCHIQ® - Valneva4 CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World’s First Chikungunya Vaccine - Valneva5 Valneva Reports Further Positive Pivotal Phase 3 Data in Adolescents for its Single-Shot Chikungunya Vaccine - Valneva6 Valneva Reports Positive 24-Month Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ® - Valneva7 https://jvi-asm-org.libproxy1.nus.edu.sg/content/jvi/88/20/11644.full.pdf8 https://cmr-asm-org.libproxy1.nus.edu.sg/content/31/1/e00104-169 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 01 Aug 2023.10 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas (who.int) Attachment 2024_09_18_IXCHIQ_Label_Extension_Application_PR_EN_Final