Biophytis has requested a pre-submission meeting with the EMA for the Marketing Authorisation of Sarconeos (BIO101) for the treatment of COVID-19

Biophytis announced that it has filed for a pre-submission meeting request with the European Medicine Agency (EMA) to discuss filing for conditional Marketing Authorisation (cMA) in Europe for Sarconeos (BIO101) in the treatment of severe form of COVID-19.

This is the first step in the regulatory process that the company is undertaking to define the eligibility and conditions for conditional Marketing Authorisation application in Europe for Sarconeos (BIO101) in the treatment of severe forms of COVID-19. A request for a pre- submission meeting with the Food and Drug Administration (FDA) for an Emergency Use Authorisation (EUA) application in the US is expected to be filed later this quarter.

Stanislas Veillet, Chief Executive Officer of Biophytis, commented: “A few weeks ago, Biophytis held a meeting with the French Health Authority in order to discuss filing an application for early access to Sarconeos (BIO101) for patients hospitalized in France, developing severe forms of COVID-19. We have prepared the application, mainly based on the positive results of the phase 2-3 COVA study, good safety profile of Sarconeos (BIO101) and medical need associated with COVID-19 pandemic, and expect to file this Early Access application this quarter, with the objective to treat the first patients in the second half of 2023 if the authorisation is granted. The meeting with the EMA will allow definition of the eligibility and conditions for filing a conditional marketing authorisation application, this time at European level. Depending on EMA’s recommendations, we could envision filing a conditional MA in the second half of 2023 or the first half of 2024. We do not forget that our main objective is to be able to treat as quickly as possible with Sarconeos (BIO101), patients developing severe form of COVID-19, at risk of respiratory failure or death in France, in Europe, but also in the United States and Brazil.”