Clinical-stage biotechnology company Biophytis SA (NasdaqCM:BPTS) (Euronext Growth Paris:ALBPS) said on Friday that it has submitted an application for Early Access Authorisation (EAA) to the French National Authority for Health (HAS).
This application, filed through pharmaceutical partner Intsel Chimos, seeks approval for the use of Sarconeos (BIO101) in the treatment of adult patients with a severe form of COVID-19 who are at risk of developing a critical form of the disease and for whom therapeutic alternatives are not appropriate.
Following positive results from the COVA phase 2-3 study, Biophytis engaged in a pre-submission meeting with HAS to review eligibility requirements. Pending approval, the early access programme will enable certain patients to receive Sarconeos (BIO101) in France while awaiting conditional Marketing Authorisation in Europe.
Biophytis anticipates a response by Q3 2023, with potential treatment initiation by Q4 2023. The company has commenced industrial-scale production of Sarconeos (BIO101) with contracted partners in order to be able to treat up to 6,000 patients if EAA is granted.
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