Rebyota Approved for the Prevention of
Recurrence of Clostridioides difficile Infection in Adults
SILVER
SPRING, Md., Nov. 30,
2022 /PRNewswire/ -- Today, the U.S. Food and Drug
Administration approved Rebyota, the first fecal microbiota product
approved by the agency. Rebyota is approved for the prevention of
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.
"Today's approval of Rebyota is an advance in caring for
patients who have recurrent
C. difficile infection," said Peter Marks, M.D., Ph.D., director of the FDA's
Center for Biologics Evaluation and Research. "Recurrent CDI
impacts an individual's quality of life and can also potentially be
life-threatening. 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."
Clostridioides difficile (C. difficile) is a
bacterium that can cause CDI, a potentially life-threatening
disease resulting in diarrhea and significant inflammation of the
colon. In the United States, CDI
is associated with 15,000-30,000 deaths annually.
The intestinal tract contains millions of microorganisms, often
referred to as the "gut flora," or "gut microbiome." Certain
situations, such as taking antibiotics to treat an infection, may
change the balance of microorganisms in the gut, allowing C.
difficile to multiply and release toxins causing diarrhea,
abdominal pain and fever, and in some cases, organ failure and
death. Other factors that can increase the risk for CDI include age
older than 65 years, hospitalization, a weakened immune system and
a previous history of CDI. After recovering from CDI, individuals
may get the infection again—often multiple times—a condition known
as recurrent CDI. The risk of additional recurrences increases with
each infection and treatment options for recurrent CDI are limited.
The administration of fecal microbiota is thought to facilitate
restoration of the gut flora to prevent further episodes of
CDI.
Rebyota is administered rectally as a single dose. Rebyota
is prepared from stool donated by qualified individuals. The
donors and the donated stool are tested for a panel of
transmissible pathogens, however, as Rebyota is manufactured from
human fecal matter, it may carry a risk of transmitting
infectious agents. In addition, Rebyota may contain food allergens;
the potential for the product to cause adverse reactions due to
food allergens is unknown.
The safety of Rebyota was assessed from two randomized,
double-blind, placebo-controlled clinical studies and from
open-label clinical studies conducted in the United States and in Canada. The participants had a history of one
or more recurrences of CDI. They received one or more doses of
Rebyota or placebo 24 to 72 hours after completion of antibiotic
treatment for their CDI; participants' CDI was under control at the
time of receipt of Rebyota or placebo. Across these studies, 978
individuals aged 18 years and older received at least one dose of
Rebyota. In one study, among 180 Rebyota recipients, when compared
to 87 placebo recipients, the most common side effects after
receiving one dose of Rebyota were abdominal pain, diarrhea,
abdominal bloating, gas and nausea.
The effectiveness of Rebyota was evaluated in an analysis of
data from a randomized, double-blind, placebo-controlled,
multicenter study. The analysis included 177 adults who received
one dose of Rebyota and 85 who received one dose of placebo in this
study. It also incorporated success rates from a different
placebo-controlled study in which 39 adults received one dose of
Rebyota and one dose of placebo and 43 adults received two doses of
placebo. Success in preventing recurrent CDI was defined as the
absence of CDI diarrhea within 8 weeks of administration of Rebyota
or placebo. In a statistical analysis that took into account both
studies, the overall estimated rate of success in preventing
recurrent CDI through 8 weeks was significantly higher in the
Rebyota group (70.6%) than in the placebo group (57.5%).
The application was granted Fast Track, Breakthrough Therapy and
Orphan designations.
The FDA granted approval of Rebyota to Ferring Pharmaceuticals
Inc.
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SOURCE U.S. Food and Drug Administration