BPTS - Biophytis seeks EMA meeting to discuss prefiling for oral COVID drug Sarconeos

2023-05-09 06:43:19 ET

• Biophytis ( NASDAQ: BPTS ) filed a request with the European Medicine Agency (EMA) for a meeting to discuss pre-submission of an application for conditional marketing authorization (cMA) of Sarconeos (BIO101) to treat severe COVID-19 in Europe.
• The French company added that a request for a pre-submission meeting with the U.S. Food and Drug Administration (FDA) for an emergency use authorization (EUA) application for the oral drug is expected to be filed later in this quarter.
• "Depending on EMA's recommendations, we could envision filing a conditional MA in the second half of 2023 or the first half of 2024," said Biophytis CEO Stanislas Veillet.
• Veillet noted that the company has already held a meeting with French regulators to discuss filing an application for early access to Sarconeos for patients hospitalized in France.
• Biophytis expects to file the Early Access application this quarter, and aims to treat the first patients in H2 2023 if  authorization is granted.

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