Biophytis has filed with the French National Authority for Health (HAS) an application for Early Access Authorisation (EAA) for Sarconeos (BIO101) in the treatment of severe forms of COVID-19
Biophytis announced that it has filed, through its pharmaceutical partner Intsel Chimos, an application for Early Access Authorisation (EAA) in France with the French National Authority for Health (HAS) for the use of Sarconeos (BIO101)1 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 the positive results of the COVA phase 2-3 study, Biophytis met with the HAS on March 9, 2023 for a pre-submission meeting to review the eligibility requirements of the application. The Company is now pursuing this regulatory process by submitting the EAA application. If the application is approved by the HAS, the early access programme will allow certain patients with severe forms of COVID-19 to be treated in France with Sarconeos (BIO101), while awaiting conditional Marketing Authorisation (MA) in Europe. Biophytis expects a response by Q3 2023 at the latest, depending on the delays taken by the HAS, and the first patients could be treated as early as Q4 2023. The industrial scale production of Sarconeos (BIO101) has been initiated with pharmaceutical subcontracting partners (CDMOs), in order to be able to treat up to 6,000 patients if the EAA is approved. Distribution will be handled by Intsel Chimos, with whom a partnership was signed in March 2023.
Stanislas Veillet, CEO of Biophytis, said: “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. With the submission of our application for the early access program, we therefore intend to accelerate the availability in France of Sarconeos (BIO101) to hospitalized patients with severe forms of COVID-19 via our partner Intsel Chimos.”
Corinne Truffault, CEO of Intsel Chimos, said: “We are delighted and very proud to accompany Biophytis in this new regulatory step to obtain the EAA for Sarconeos (BIO101) in the treatment of severe forms of Covid-19. In parallel, we are preparing to ensure the distribution and availability of this treatment to patients in France as soon as the EAA is approved by the HAS.”