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FDA Approves Nucala as Add-on to Treat Severe Asthma

GlaxoSmithKline’s mepolizumab is an injection administered once every four weeks

Mepolizumab (Nucala, GlaxoSmithKline PLC) has received FDA approval to treat patients with severe asthma attacks in combination with other drugs. Nucala is the first approved biologic therapy that targets interleukin-5, which plays a key role in regulating the function of eosinophils — inflammatory cells known to be important in asthma.

Mepolizumab is an injection administered once every four weeks that is approved as an add-on maintenance treatment for patients ages 12 and older. The mepolizumab phase II/III clinical development program involved nine studies and more than 1,300 patients. Three key clinical trials — DREAM (MEA112997), MENSA (MEA115588), and SIRIUS (MEA115575) — have established the efficacy and safety profile of mepolizumab. In controlled trials, patients who received mepolizumab 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. Infections with herpes zoster, 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.

The biologics license application for mepolizumab was submitted to the FDA in November 2014.

About 26 million people in the United States suffer from asthma, and up to 10% suffer from severe asthma. 

Source: GSK, November 4, 2015; Reuters, November 5, 2015.

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