GlaxoSmithKline PLC's Nucala therapy has been approved to treat patients with severe asthma attacks in combination with other drugs, the Food and Drug Administration said Wednesday.

Mepolizumab, commercialized as Nucala, is an injection administered once every four weeks that is approved as an add-on maintenance treatment for patients aged 12 and older.

In controlled trials, patients who received Nucala had fewer asthma attacks that required hospitalization or emergency-room visits and reported longer breaks between asthma attacks.

The most common reported side effects included redness, swelling and itching in the injection area, back pain and fatigue. Herpes zoster infections, the virus that causes shingles, were also reported in the clinical trials. The company said patients should consider a varicella vaccination, if medically appropriate, before starting therapy with Nucala.

Shares, down 0.33% this year, edged up 0.54% to $42.83 in late trading.

Write to Maria Armental at maria.armental@wsj.com

 

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(END) Dow Jones Newswires

November 04, 2015 19:25 ET (00:25 GMT)

Copyright (c) 2015 Dow Jones & Company, Inc.
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