(BFM Bourse) – The American Medicines Agency has awarded the designation of “breakthrough therapy”, which qualifies a therapeutic breakthrough considered as major, to the experimental vaccine of Valneva against chikungunya. What to facilitate its regulatory course.
The Nantes biotechnology company Valneva is developing a treatment that represents, if approved, a potential therapeutic breakthrough against the chikungunya virus, recognizes the US Medicines Agency (the FDA). In an adverse market, the stock of the French company (listed on both sides of the Atlantic) rose 1.40% to 11.61 euros Thursday around 9:30 am after this announcement, which implies a regulatory process facilitated with the FDA , and therefore a potential faster time to market in a disease considered to be a major threat to public health by the WHO.
Indeed, if the direct mortality from the virus is low, the morbidity is high and the virus, transmitted by mosquitoes, often causes sudden epidemics with high attack rates (affecting one third to three quarters of the population in the areas where the virus is circulating).
The Food and Drug Administration (FDA) has a range of procedures designed to facilitate patient access to the most promising drugs in high therapeutic need, but Breakthrough Therapy Designation (BTD) is the most difficult to obtain.
Only 25% of requests granted
According to an Evercore ISI study (covering designations awarded between 2012 and 2014) only 25% of requests to obtain BTD status were satisfied, compared to 70% of requests to obtain “fast track” status. It is up to the company to request this status, the Medicines Agency not being able to grant it on its own.
According to the website of the Medicines Agency, the fast track is attributed to a product aimed at treating a serious disease and having clinical data demonstrating a potential response to an unmet therapeutic need (the attribution is even automatic when the product is address to an infectious disease from a predetermined list). For BTD, the product must already present clinical evidence of its ability to provide a substantial improvement over existing therapies.
The American agency had already granted the “VLA1553” project fast track status (in December 2018) while the European Medicines Agency (EMA) granted a close status, says PRIME, in October 2020.
“Long-lasting protection with just one injection”
“We are delighted that the FDA sees VLA1553 as a breakthrough program. Chikungunya is a major and growing threat to public health and VLA1553 aims to provide long-lasting protection against the chikungunya virus with a single injection,” said Juan Carlos Jaramillo, medical director of Valneva, promising to continue working in agreement with the FDA to bring a preventive solution to chikungunya to market as soon as possible.
Concretely, the firm should announce during the summer the initial results of the phase 3 study (final phase of clinical trials before possible marketing). The primary endpoint of this trial, designated “VLA1553-301”, is to demonstrate the safety and immunogenicity of the vaccine 28 days after a single injection.
Guillaume Bayre – © 2021 BFM Bourse
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