(RxWiki News) Patients with severe asthma may soon have another treatment option to add to their current medications.
The US Food and Drug Administration (FDA) Wednesday approved Nucala (mepolizumab) to treat asthma in patients 12 and older. This GlaxoSmithKline drug was approved for use along with currently available asthma drugs.
“This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma,” said Badrul Chowdhury, MD, PhD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, in a press release.
Asthma affects an estimated 22 million patients in the US, according to the FDA. This chronic disease of the airways causes inflammation, which can lead to trouble breathing. Severe asthma attacks can be life-threatening.
Patients taking the newly approved Nucala will receive an injection of the drug by a health care professional one time every four-week period. The drug works by targeting a type of white blood cell that is thought to play a part in asthma's development.
Three studies of Nucala found that the drug treated severe asthma more effectively than a placebo (fake treatment). The patients in these studies received either Nucala or a placebo, along with current asthma drugs. Patients who received Nucala were less likely than the placebo group to be hospitalized for an asthma attack. Also, Nucala appeared to delay asthma-related events more than current therapies alone.
Reported side effects of Nucala included skin reactions at the injection site, headache, back pain and weakness. The FDA also noted that some "hypersensitivity reactions" — including swelling of the tongue, mouth and face, dizziness and hives, among others — can occur within "hours or days of being treated with Nucala."
Some patients reported infection with herpes zoster, the virus that causes shingles, after receiving Nucala.
