(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.
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.