Valneva has filed a marketing application for its Chikungunya vaccine with the EMA and revealed an accelerated assessment by the CHMP.
Saint-Herblain (France), October 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the submission of a marketing application with the European Medicines Agency (EMA) for approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553. Valneva was also granted accelerated assessment[1] for the application by EMA’s Committee for Medicinal Products for Human Use (CHMP) based on the vaccine candidate’s “major interest for public health and therapeutic innovation”.
VLA1553 is currently the first and only chikungunya vaccine candidate worldwide for which regulatory review processes are underway. A Biologic License Application (BLA) is currently under priority review by the U.S. Food and Drug Administration (FDA)[2] with a Prescription Drug User Fee Act (PDUFA) action date planned for the end of November 2023[3]. Additionally, a marketing application is under review by Health Canada[4].
Valneva
If approved, VLA1553 could become the first licensed chikungunya vaccine available to address this unmet medical need.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “We welcome EMA’s accelerated assessment and will work closely with them to bring this vaccine to market. Chikungunya virus, or CHIKV, is a serious and debilitating mosquito-borne viral infection that poses a significant unmet need and the risk of chikungunya spreading in Europe is relatively high due to the possibility of infected travelers[5]. No vaccine or specific treatments are currently available for this debilitating disease. We will continue to work diligently to bring VLA1553 to different territories as soon as possible.”
The regulatory submissions with the EMA, FDA and Health Canada follow final pivotal Phase 3 data in March 2022[6] (Lancet article), final lot-to-lot consistency results in May 2022[7], twelve-month persistence data in December 2022[8] and positive initial Phase 3 safety data in adolescents[9].
VLA1553 was granted PRIority MEdicine (PRIME) designation by EMA in 2020 and received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively.
About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[10]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating.
The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries[11]. As of July 2022, more than three million cases have been reported in the Americas[12] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.
About VLA1553
VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 110 countries[13]. It has been designed by deleting a part of the chikungunya virus genome.
Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022[14], final lot-to-lot consistency results in May 2022[15], positive twelve-month persistence data in December 2022[16] and positive initial Phase 3 safety data in Adolescents[17]. The pivotal Phase 3 data were published in The Lancet[18](article link), the world’s leading peer-reviewed medical journal, in June 2023.
If approved, VLA1553 would expand Valneva’s existing commercial vaccines portfolio and as such, Valneva intends to commercialize this vaccine, leveraging its existing manufacturing and commercial operations.
To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[19]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[20], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.
About Valneva SE
We 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 two proprietary travel vaccines as well as certain third-party vaccines leveraging our established commercial infrastructure.
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, potentially the world’s first vaccine against the chikungunya virus, as well as vaccine candidates against the Zika virus and other global public health threats.
