First Fecal Microbiota Available in US

Ferring Pharmaceuticals announced their fecal microbiota product, RBX2660 (Rebyota), is available for treatment in the United States.

“With the launch of Rebyota, Ferring is proud to offer an urgently needed new treatment option for adults suffering from the burden of recurrent C diff infection,” Brent Ragans, president, Ferring Pharmaceuticals US, said in a statement.

The availability of this new microbiota-based live biotherapeutic provides a novel treatment option for adults suffering from recurrent C diff (CDI) infection.

Back in November, the FDA approved this first ever fecal microbiota product, and was indicated in adult patients who have already completed an antibiotics regimen for recurrent CDI.

“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said at the time. “As the first FDA-approved fecal microbiota product, today’s action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI.”

In its product launch, Ferring has developed resources for both patients and clinicans.

For patients, the company is providinga variety of offerings, including co-pay and patient assistance programs, to allow for access to the therapy. Information about these programs is available from healthcare providers or at REBYOTA.com.

Ferring is offering educational programs as well as support programs for clinicians. The REBYOTA CONNECT program provides guidance to healthcare providers about access services, as well as information about co-pay and patient assistance programs. Information is available at REBYOTAHCP.com.

Gastroenterologist Paul Feuerstadt, MD, says medical science has been exploring a different, more holistic treatment approach for patients with recurrent CDI. He says patients experience a depletion of their microbiota after CDI treatment, and for some patients they struggle to grow it back. In these cases after the standard-of-care using antimicrobials, the use of a microbiota therapeutic may benefit these patients and help them to regain their own bacteria.

In this previous interview with Contagion, Feuerstadt talks about how clinicians can utilize this therapy.