(MENAFN- Trend News Agency)
The U.S. health regulator on Wednesday approved
Switzerland-based Ferring Pharmaceuticals' fecal transplant-based
therapy to reduce the recurrence of a bacterial infection, making
it the first therapy of its kind to be cleared in the United
States, trend reports with reference to reuters .
The therapy, Rebyota, targets Clostridium difficile, or C.
difficile – a superbug responsible for infections that can cause
serious and life-threatening diarrhea. In the United States, the
infection is associated with 15,000-30,000 deaths annually.
While this is the first such therapy approved by the Food and
Drug Administration (FDA) for recurrent C. difficile infections,
fecal microbiota transplants – classified by the regulator as
investigational – have long been the standard of care in the U.S.
for this condition.
'As the first FDA-approved fecal microbiota product, (the)
action represents an important milestone, as it provides an
additional approved option to prevent recurrent CDI,' said Peter
Marks, director of the agency's Center for Biologics Evaluation and
Rebyota is delivered through an enema and works by replenishing
good gut bacteria through samples of microbes distilled from faeces
of healthy donors.
Approval for the therapy comes on the back of a positive vote
from the regulator's advisers in September, as most on the panel
sought standardization of the therapy.
Ferring, which gained the therapy through its 2018 purchase of
U.S.-based Rebiotix Inc, was not immediately available for a
comment on pricing and availability of the therapy.
Besides Ferring, other companies including Seres Therapeutics,
which is developing an oral treatment, are working on similar
therapies based on fecal microbiota transplantation.
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