(CercleFinance.com) – Biophytis announced on Monday that it has started the process of requesting early access in France for its experimental treatment for severe forms of Covid-19, with the objective of obtaining authorization in the second quarter of 2023.
This program would allow patients hospitalized in France with a severe form of Covid9 to access its lead drug candidate, Sarconeos (BIO101), which reduced the risk of respiratory failure and early death by 44% in a positive clinical study. phase 2-3.
In France, early access is granted by the HAS after consulting the National Agency for the Safety of Medicines and Health Products (ANSM).
This is a system that allows the provision and early financial coverage, on an exceptional and derogatory basis, of certain drugs responding to an uncovered therapeutic need.
A pre-submission meeting with HAS is scheduled for March and the early access authorization application should be submitted immediately with the aim of obtaining authorization in the second quarter of 2023.
Biophytis says it is continuing to prepare conditional marketing authorization applications in Europe and due to the health emergency in the United States.