FDA OKs Nucala for Eosinophilic Granulomatosis With Polyangiitis
TUESDAY, Dec. 12, 2017 -- Nucala (mepolizumab) has been approved by the U.S. Food and Drug Administration as the first drug to treat adults with eosinophilic granulomatosis with polyangiitis, a rare autoimmune disease that leads to vasculitis.
Other symptoms of the condition, formerly called Churg-Stress syndrome, include asthma and high levels of eosinophils. 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," Badrul Chowdhury, M.D., Ph.D., director of the FDA's Division of Pulmonary, Allergy and Rheumatology Products, said in a statement.
Nucala, a once-monthly injection, was first approved in 2015 to treat patients 12 and older with severe asthma with an eosinophilic phenotype, the FDA said. The drug's most common side effects include headache, injection-site reaction, back pain, and fatigue. Patients who are prone to a hypersensitive allergic reaction shouldn't take the drug, and those who are taking systemic or inhaled corticosteroids should not discontinue them abruptly upon beginning treatment with Nucala.
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
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