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Seres Therapeutics Announces FDA Acceptance of Biologics License Application for Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection for Priority Review
– If approved, SER-109 expected to be the first-ever FDA-approved oral microbiome therapeutic – – PDUFA target action date is April 26, 2023, with
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n– If approved, SER-109 expected to be the first-ever FDA-approved oral microbiome therapeutic –\n\n– PDUFA target action date is April 26, 2023, with anticipated launch soon thereafter –\n\n– FDA advised that they are not currently planning to hold an Advisory Committee Meeting to discuss the SER-109 application –\n\n– Company to hold commercial investor event on December 8, 2022 –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for investigational oral microbiome therapeutic SER-109 for the prevention of recurrent C. difficile infection (rCDI). The application has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2023. The FDA advised that they are not currently planning to hold an Advisory Committee Meeting to discuss the SER-109 application.\n\n“We are delighted by the FDA’s BLA acceptance for priority review, as we believe that SER-109 has the potential to fundamentally transform the management of rCDI,” said Lisa von Moltke, M.D., Chief Medical Officer at Seres. “We are working closely with the FDA to bring forth this entirely new treatment modality alongside our collaborator, Aimmune Therapeutics, Inc., a Nestlé Health Science Company.”\n\nSER-109 is an investigational microbiome therapeutic composed of purified Firmicutes spores for the treatment of rCDI, which shows promise to improve the current standard of care for this debilitating disease. With nearly 170,000 cases of rCDI each year in the U.S., it is one of the top three most urgent bacterial threats in the country, according to the Centers for Disease Control and Prevention (CDC), and is a leading cause of hospital-acquired infection.\n\n“We are working as quickly as possible to bring this first-ever oral microbiome therapeutic to patients most in need, if approved,” said Eric Shaff, President and Chief Executive Officer at Seres. “Today’s milestone is the result of tremendous hard work and perseverance by our team, and we look forward to collaborating with the FDA through the ongoing review process.”\n\nThe application is supported by the results of a completed Phase 3 development program including ECOSPOR...