FDA Approves GlaxoSmithKline's Nucala as Add-on to Treat Severe Asthma
November 04 2015 - 7:40PM
Dow Jones News
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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