Drugs

Ferring’s Fecal Microbiota Product Approved for C.diff

FDA has approved Ferring Pharmaceuticals’ Rebyota (fecal microbiota) for preventing recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older. It is for use after an individual has completed antibiotic treatment for recurrent CDI, an agency release says.

FDA says Rebyota is prepared from stool donated by qualified individuals, and then administered rectally as a single dose. Approval was based on data from 177 patients. The success rate in “preventing recurrent CDI through 8 weeks was significantly higher in the Rebyota group (70.6%) than in the placebo group (57.5%),” it says.

Leading up to approval, FDA this week granted in part and denied in part a 7/2/20 petition submitted by the Microbiome Therapeutic Innovation Group (MTIG) asking the agency to take certain actions regarding fecal microbiota for transplantation (see story).

The agency this week also published a final guidance requested in the petition. The guidance “informs members of the medical and scientific community and other interested parties that FDA intends to exercise enforcement discretion under limited circumstances, regarding the IND requirements … for the use of FMT to treat C. difficile infection not responding to standard therapies,” it says. “In light of safety concerns with respect to centralized manufacturing of FMT products in stool banks, the guidance explains that FDA’s enforcement policy does not apply to FMT obtained from a stool bank.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome