Biophytis has requested a pre-submission meeting with the FDA for an Emergency Use Authorization of Sarconeos (BIO101) for the treatment of COVID-19
Biophytis announced that it has filed for a pre-submission meeting request with the Food and Drug Administration (FDA) to discuss filing for Emergency Use Authorization (EUA) in the United States for Sarconeos (BIO101) in the treatment of severe forms of COVID- 19.
This is a further key step in defining the conditions for rapid market access in the United States for Sarconeos (BIO101) in the treatment of severe forms of COVID-19, following the similar process initiated with the European Medicine Agency (EMA) in May, in a context where COVID-19 is still associated with a public health problem in the United States and in Europe.
Stanislas Veillet, Chief Executive Officer of Biophytis, commented: “We are actively pursuing our roadmap by initiating discussions with the FDA to bring our drug candidate to patients suffering from severe forms of COVID-19 in the United States. Like influenza, this pathology has become an endemic respiratory infectious disease that can lead to Acute Respiratory Distress Syndrome (ARDS) in elderly, immunocompromised or co- morbid patients. According to the WHO, the medical need remains high, with several thousand deaths per week in the United States and Europe. In this context, the positive clinical results of the phase 2-3 COVA study, with a 44% reduction in the risk of respiratory failure or early death, suggests that Sarconeos (BIO101) could become an important new therapeutic option alongside antiviral or anti-inflammatory treatments. We look forward to starting discussions with the FDA, and depending on feedback from this agency, we could consider filing an Emergency Use Application by the end of 2023 or in the first half of 2024.”