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You are here: Home / Health / FDA gives approval to Entyvio for Crohn’s disease and Ulcerative Colitis

FDA gives approval to Entyvio for Crohn’s disease and Ulcerative Colitis

May 21, 2014 Posted by Contributor

Entyvio

Entyvio

The U.S Food and Drug Administration has given approval to Entyvio(Vedolizumab) which is mainly for treating adults with Crohn’s Disease and Ulcerative Colitis, that are considered to be 2 severe forms of gastrointestinal conditions. This approval is only for those people who have tried out standard therapies such as tumor necrosis or corticosteroids factor blocking medications but have failed.

Ulcerative Colities affects around 620,000 Americans and causes ulcers and inflammation in the large intestine. Thus, as per an FDA’s statement in a news release, this leads to diarrhea, bleeding and abdominal discomfort.

People with Crohn’s disease experience irritation or inflammation in any part of the gastrointestinal tract. FDA further stated that more than 500,000 have been diagnosed with Crohn’s.

Fever, nausea, joint pain are the most common side effects of Entyvio. There are some more serious adverse reactions too that are observed during clinical testing. This includes allergy-like hypersensitivity reaction and serious infection.  Although progressive Multifocal Leukoencephalopathy, a rare and fatal nervous system infection was not contracted by any clinical trial participants, FDA states that users of Entyvio should be more monitored for signs and symptoms of PML.

Takeda Pharmaceuticals America, based in Deerfield, III, markets Entyvio. 

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