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First Drug, Nucala (Mepolizumab), Approved for Rare Eosinophilic Granulomatosis With Polyangiitis

TUESDAY, Dec. 12, 2017 -- Nucala (mepolizumab) has been approved by the U.S. Food and Drug Administration as the first remedy to treat adults with eosinophilic granulomatosis with polyangiitis, a rare autoimmune disease that leads to inflammation of the blood vessels.

Other symptoms of the condition, formerly called Churg-Stress syndrome, include asthma and an overabundance of an infection-fighting white blood cell called an eosinophil. The inflamed blood vessels may affect the lungs, intestines, skin, heart and nervous system.

The condition affects a total of about 11 out of every one million people in United States, the FDA said Tuesday in a news release.

"Patients taking Nucala in clinical trials reported a significant improvement in their symptoms," said Dr. Badrul Chowdhury, director of the FDA's Division of Pulmonary, Allergy and Rheumatology Products.

Nucala, a once-monthly injection, was first approved in 2015 to treat people 12 and older with a certain type of severe asthma, the FDA said. The drug's most common side effects include headache, injection-site reaction, back pain and fatigue.

People who are prone to a "hypersensitive" allergic reaction shouldn't take the drug, and those who are taking an inhaled corticosteroid medication to treat asthma should not abruptly stop the asthma remedy, the agency warned.

Nucala is produced by the British pharma firm GlaxoSmithKline, whose U.S. headquarters are in Warren, N.J.

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Posted: December 2017