New Rx Approved for Rare Autoimmune Disease

Nucala (mepolizumab) approved for eosinophilic granulomatosis with polyangiitis

(RxWiki News) The US Food and Drug Administration (FDA) has approved the first drug to treat a rare condition that causes inflammation in the wall of the body's blood vessels.

This new approval is for Nucala (mepolizumab). The FDA approved it to treat eosinophilic granulomatosis with polyangiitis (EGPA) in adults.

EGPA, formerly known as Churg-Strauss syndrome, is a rare autoimmune disease that causes vasculitis. Vasculitis is inflammation in the wall of blood vessels.

This health condition is also marked by asthma and high levels of eosinophils (an infection-fighting type of white blood cell). Up to 2.66 new cases of EGPA per 1 million people are thought to be diagnosed each year.

“The expanded indication of Nucala meets a critical, unmet need for EGPA patients," said Dr. Badrul Chowdhury, director of the FDA's Division of Pulmonary, Allergy, and Rheumatology Products, in a press release. "It’s notable that patients taking Nucala in clinical trials reported a significant improvement in their symptoms."

Nucala was already approved to treat a specific subgroup of asthma (asthma with an eosinophilic phenotype). This medication is available as an injection given under the fatty layer of the skin once every four weeks by a health care professional. It is injected into the upper arm, thigh or abdomen.

Common side effects may include headache, injection-site reactions, back pain and feeling tired. This medication is not recommended to treat acute bronchospasm or acute severe asthma.

The FDA granted approval of this medication to GlaxoSmithKline.