Ferring Pharmaceutical’s achieved an innovative milestone in C.Diff treatment when it launched Rebyota, the first FDA approved Fecal Microbiota Transplant (FMT) therapy, earlier this year
EXTON, Pa., May 22, 2023 — Prior to Ferring Pharmaceuticals’ Rebyota, physicians interested in using fecal microbiota transplants (FMT) to treat patients with recurrent clostridioides difficile (C.Diff) had to turn to specialized centers using off-label processes to synthesize an FMT formulation. The FDA approval of Rebyota provided a welcomed level of clinical and public assurance that the manufacturing process used to create microbiota treatments from human fecal material is well regulated and safe.
While overall patient use is small, insight from Spherix Global Insights’ Launch DynamixTM RebyotaTM finds Rebyota is capturing 1 in 5 FMT treated C.Diff patients and physicians expect to expand approved FMT treatment well beyond what has been seen with off-label formulations.
Despite needing to manage logistical and administration characteristics of Rebyota, nearly a third of gastroenterologists and infectious disease specialists surveyed have treated at least one patient in the first three months of availability with expectations that trial will rise to over half of doctors within a year of launch. Doctors with experience using Rebyota report moderate to high satisfaction.
While this bodes well for Ferring’s trailblazing treatment, several headwinds may temper the uptake of the nascent launch. Rebyota is administered through a single enema dose in a physician’s office. While doctors interviewed by Spherix noted patients burdened with recurrent C.Diff are sufficiently motivated to accept a rectally delivered medication, most agreed an oral option will be preferred by patients.
Rebyota also requires special handling, including maintaining specific cold storage parameters prior to use and a relatively short shelf life. Gastroenterologist staff must perform additional work to coordinate patient schedules with procurement, storage, and preparation of the therapy for delivery.
Vowst, the first approved orally delivered FMT avoids these burdens, allowing patients to treat themselves at home, with no extraordinary storage concerns.
Spherix further found that doctors see value in both treatments for specific patient populations, suggesting that together, Rebyota and Vowst will expand the overall size of the FMT treated population. The CDC highlights 20%-35% of C.diff patients will experience a recurrence following their first antibiotic treatment, with that rate rising to over 50% for patients experiencing multiple recurrences. FMT therapy promises to help reduce the burden of recurrent disease when used earlier in the recurrence cycle.
Spherix will begin tracking Vowst alongside Rebyota once the new oral therapy becomes available for doctors to prescribe in June or July.
About Launch Dynamix™
Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.
About Spherix Global Insights
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Spherix Global Insights Contacts
Geoff Red, Franchise Leader, Gastroenterology
geoff.red@spherixglobalinsights.com
Scott Upham, Corporate Communications
scott.upham@spherixglobalinsights.com
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