-- Robert Preidt
WEDNESDAY, May 21, 2014 (HealthDay News) -- A new drug to treat
adults with ulcerative colitis and Crohn's disease has been
approved by the U.S. Food and Drug Administration.
The agency said Tuesday that injections of Entyvio (vedolizumab)
can be used to treat patients with moderate to severe ulcerative
colitis and Crohn's disease who have had poor responses to one or
more of the current standard therapies: corticosteroids,
immunomodulators, or tumor necrosis factor blocker medications.
The FDA's approval of the new drug is based on two clinical
trials of about 900 patients with ulcerative colitis, and three
clinical trials of about 1,500 patients with Crohn's disease.
Ulcerative colitis causes inflammation and ulcers in the inner
lining of the large intestine and can lead to abdominal discomfort,
bleeding and diarrhea. It affects about 620,000 Americans. Crohn's
can cause inflammation and irritation in any part of the digestive
tract. It affects more than 500,000 Americans.
"Ulcerative colitis and Crohn's disease are debilitating diseases that impact the quality of life of those who have these conditions," Dr. Amy Egan, acting deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
"Although there is no cure for these conditions, [Tuesday's] approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy to help control their symptoms," she added.
Entyvio is a type of drug called an "integrin receptor
antagonist." These drugs improve the function of cell-to-cell
interactions, the FDA said. Another type of integrin receptor
antagonist -- Tysabri (natalizumab) -- has been linked with a rare
and often fatal infection of the central nervous system called
progressive multifocal leukoencephalopathy (PML).
No cases of PML occurred in patients taking part in the clinical
trials of Entyvio. But the risk for patients taking the new drug
remains unclear and doctors should monitor patients who are taking
Entyvio for any signs of PML, the FDA said.
The FDA told Entyvio's maker, Takeda Pharmaceuticals America
Inc., that it must conduct a post-approval study to further
investigate the risk of PML among patients taking Entyvio.
In the clinical trials, the most common side effects among
patients taking Entyvio included headache, joint pain, nausea and
fever. The most serious side effects included major infections,
injection-related reactions and liver toxicity.
The U.S. National Library of Medicine has more about
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