Roche: FDA priority review for REGEN-COV
(CercleFinance.com) - Regeneron Pharmaceuticals today announced that the US FDA has accepted for priority review a Biologics License Application (BLA) for REGEN-COV (casirivimab and imdevimab) for the treatment of COVID-19 in non-hospitalised patients and for prophylaxis in certain individuals.
The BLA is supported by two positive Phase 3 trials involving over 6,000 patients that evaluated the efficacy and safety of REGEN-COV
A second BLA submission focusing on the treatment of patients hospitalised with COVID-19 is expected later this year.
The European Medicines Agency also announced this week that it will review the marketing authorisation application.
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The BLA is supported by two positive Phase 3 trials involving over 6,000 patients that evaluated the efficacy and safety of REGEN-COV
A second BLA submission focusing on the treatment of patients hospitalised with COVID-19 is expected later this year.
The European Medicines Agency also announced this week that it will review the marketing authorisation application.
Copyright (c) 2021 CercleFinance.com. All rights reserved.