FDA Approves Seres Microbiota-Based Drug

Cambridge-based Seres Therapeutics and Nestlé Health Science have announced FDA approval of Vowst, an orally administered microbiota-based therapeutic to prevent recurrence of C. difficile Infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). Vowst was previously granted Breakthrough Therapy and Orphan Drug Designations by the FDA.

Recurrent CDI represents significant unmet need and is a leading cause of hospital-acquired infection that can result in severe illness and death. Based on data from the CDC, the companies estimate 156,000 episodes in the U.S. in 2023. “Since being founded by Flagship Pioneering over a decade ago, Seres has led the development of microbiome therapeutics, and today’s FDA approval of Vowst as the first orally administered microbiota-based therapeutic for the prevention of recurrent C. difficile infection marks a tremendous milestone for the patient community, and for Seres,” said Eric Shaff, Seres President and CEO

In July 2021, Seres and Nestlé Health Science entered into an agreement to jointly commercialize Vowst in the U.S. and Canada. Nestlé Health Science is leveraging its global pharmaceutical business and assuming the role of lead commercialization party, including the utilization of its existing infrastructure, gastrointestinal sales force and payer access team.

Seres is due to receive a $125 million milestone payment from Nestlé Health Science associated with the FDA approval of Vowst. Upon Vowst commercialization, each company will be entitled to share equally in commercial profits and losses. (Source: Seres Therapeutics Website, 26 April, 2023)