FDA OKs Nucala for Eosinophilic Granulomatosis With Polyangiitis

Share this content:
FDA OKs Nucala for Eosinophilic Granulomatosis With Polyangiitis
FDA OKs Nucala for Eosinophilic Granulomatosis With Polyangiitis

TUESDAY, Dec. 12, 2017 (HealthDay News) -- 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.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Trending Activities

All Professions

Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

CDC: Progress in HIV Prevention Has Stalled in the United States

CDC: Progress in HIV Prevention Has Stalled in ...

Agency says effective HIV prevention, treatment not reaching those who could most benefit

AAAAI: Egg Oral Immunotherapy Shows Sustained Benefit in Children

AAAAI: Egg Oral Immunotherapy Shows Sustained Benefit in ...

All children with sustained unresponsiveness ingested concentrated and baked egg

Prenatal Vitamin Intake in Early Pregnancy May Cut Autism Risk

Prenatal Vitamin Intake in Early Pregnancy May Cut ...

ASD risk down for children whose mothers took prenatal vitamins during first month of pregnancy

is free, fast, and customized just for you!




Already a member?

Sign In Now »