BPTS - Biophytis seeks early access authorization of COVID drug Sarconeos in France

May, 26 2023 07:48 AM Biophytis SA

2023-05-26 07:48:57 ET

Biophytis ( NASDAQ: BPTS ), via its pharmaceutical partner Intsel Chimos, filed an application for Early Access Authorization (EAA) of Sarconeos (BIO101) to treat severe forms of COVID-19 in France.
The filing to the French National Authority for Health (HAS) is for using Sarconeos to treat adult patients with a severe COVID-19 who are at risk of developing a critical form of the disease and for whom therapeutic alternatives are not appropriate.
If the EAA application is approved by HAS, then certain patients could be treated in France with Sarconeos under the early access program, while awaiting conditional approval in Europe, the company added.
Biophytis noted that industrial scale production of Sarconeos has been started with pharmaceutical subcontracting partners (CDMOs), to be able to treat up to 6,000 patients if the EAA is approved.
Distribution will be handled by Intsel under a partnership which was signed in March.
"We have demonstrated, through the positive results of the COVA study, a statistically significant 44% reduction in the risk of respiratory failure or early death," said Biophytis' CEO Stanislas Veillet.

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