In a groundbreaking development for the vaccine development sector, biotech company Valneva SE announced, that the U.S. Food and Drug Administration (FDA) has approved IXCHIQ® – the world’s first chikungunya vaccine.
The single-dose, live-attenuated vaccine, IXCHIQ® is specifically designed for the prevention of diseases caused by the chikungunya virus (CHIKV). On Thursday 9th November, the FDA confirmed that it has approved IXCHIQ® for individuals 18 years of age and older who are at increased risk of infection. The indication is approved under accelerated approval based on anti-CHIKV neutralizing antibody titers. Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said:
“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions. Today’s approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options.”
Through this U.S. approval, IXCHIQ® becomes the world’s first licensed chikungunya vaccine available to address this unmet medical need. Notably, this achievement underscores Valneva’s track record of successfully advancing vaccines from early research and development (R&D) stages to regulatory approval; IXCHIQ® is the third such vaccine in this impressive lineup.
In Valneva’s press release Thomas Lingelbach, Chief Executive Officer of Valneva, said:
“As a leading specialty vaccines company, we aim to deliver vaccines in areas of unmet medical need supporting our vision to contribute to a world in which no one dies or suffers from a vaccine preventable disease. As such, today marks an important step forward in the prevention of chikungunya. I would like to personally express a huge thank you to everyone who helped make this possible. I would also like to recognize CEPI and Instituto Butantan for their collaboration in potentially bringing this product to low- and middle-income countries.”
Valneva intends to begin commercializing IXCHIQ® in the U.S. early next year while continuing to support the work towards an anticipated vote from the Advisory Committee on Immunization Practices (ACIP) at the end of February 2024. Valneva has also applied for marketing approval for IXCHIQ® in Canada and the EU.
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, stated:
“Today, it is estimated that more than 75% of the world’s population lives in areas at risk of CHIKV transmission due to factors such as global warming and climate change. Chikungunya has already spread to over 110 countries and is currently regarded as one of the most likely viral infections to emerge in new geographic areas. Morbidity is high with 43% of CHIKV patients suffering from chronic chikungunya where joint pain, fatigue, and potentially debilitating effects may last from months to years and can have substantial impact on daily activities. As we are introducing IXCHIQ®, our objective is to make this vaccine available to the largest number of people that will benefit from it.”
The approval has been granted Fast Track and Breakthrough Therapy designations and the application was granted Priority Review. In addition, the FDA has awarded the manufacturer of a tropical disease priority review voucher, under a provision included in the Food and Drug Administration Amendments Act of 2007. This provision aims to encourage the development of new drugs and biological products for the prevention and treatment of certain tropical diseases.
Valneva reported final pivotal Phase 3 data for the vaccine in March 2022 showing a 98.9% seroresponse rate at 28 days with a single vaccination and final lot-to-lot consistency results in May 2022. IXCHIQ®-induced seroresponse was sustained over time with a 96.3% seroresponse rate six months post-vaccination. Valneva will continue to evaluate antibody persistence for at least five years. The Company’s pivotal Phase 3 results were published in the Lancet in June 2023.