Brief: Biophytis Receives Brazil's Approval For Sarconeos For Hospitalized Covid-19 Patients

Biophytis SA

03/02/2022 08:19

Feb 3 (Reuters) - Biophytis SA  ALBPS.PA :
    * BIOPHYTIS RECEIVED APPROVAL FROM ANVISA (BRAZIL) TO GIVE
ACCESS
TO SARCONEOS (BIO101) TO HOSPITALIZED COVID-19 PATIENTS THROUGH
AN EXPANDED ACCESS PROGRAM
    * ANVISA APPROVED BIOPHYTIS' EXPANDED ACCESS PROGRAM FOR
HOSPITALIZED PATIENTS WITH SEVERE COVID-19, MECHANICALLY
VENTILATED IN INTENSIVE CARE UNIT
    * SARCONEOS TREATMENT TO BE GIVEN TO MAXIMUM OF 80 PATIENTS
MECHANICALLY VENTILATED IN INTENSIVE CARE UNITS (ICUS) OF
BRAZILIAN HOSPITALS
    * IN PARALLEL, SARCONEOS IS BEING EVALUATED IN PHASE 2-3
STUDY
(COVA), IN EUROPE, LATIN AMERICA, AND US, FOR TREATMENT OF
NON-INTUBATED HOSPITALIZED PATIENTS WITH SEVERE RESPIRATORY
MANIFESTATIONS OF COVID-19
    * BASED ON THIS FIRST APPROVAL AND UPCOMING COMPLETION OF
COVA
STUDY DURING H1 2022, BIOPHYTIS IS WILLING TO EXTEND EAP
SUBMISSION TO OTHER TERRITORIES IN WORLD
    * BRAZIL IS FIRST COUNTRY TO APPROVE EAP TO GIVE ACCESS TO
SARCONEOS (BIO101) TO HOSPITALIZED COVID-19 PATIENTS

Source text: https://bit.ly/3ro5ecY
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