May 20 U.S. health regulators on Tuesday
approved a drug from Japan's Takeda Pharmaceutical Co Ltd
to treat the chronic debilitating inflammatory diseases
ulcerative colitis and Crohn's disease.
The Food and Drug Administration said it had approved
vedolizumab, which will be sold under the brand name Entyvio,
for patients who failed to gain adequate relief from one or more
current standard treatments.
"Although there is no cure for these conditions, today's
approval provides an important new treatment option for patients
who have had an inadequate response to conventional therapy to
help control their symptoms," Amy Egan, acting deputy director
of the Office of Drug Evaluation III in the FDA's Center for
Drug Evaluation and Research, said in a statement.
The injected biotech drug, from a class known as integrin
receptor agonists, works by blocking circulating inflammatory
cells from reaching areas of inflammation in the digestive
Ulcerative colitis, which affects about 620,000 Americans,
causes inflammation and ulcers in the inner lining of the large
intestine that can lead to abdominal pain, gastrointestinal
bleeding, and diarrhea.
Crohn's, affecting more than half a million Americans, can
cause inflammation, swelling, and irritation of any part of the
The most serious risks associated with Entyvio include
serious infections, hypersensitivity and infusion-related
reactions and liver toxicity, the FDA said.
(Reporting by Bill Berkrot; Editing by Grant McCool)