US FDA advisory panel recommends GSK's mepolizumab for adults with severe asthma

12 June 2015

There was good news for UK pharma major GlaxoSmithKline (LSE: GSK) yesterday, when a US Food and Drug Administration advisory panel came to a favorable conclusion on the company’s Biologics License Application (BLA) for mepolizumab, proposed trade name Bosatria, as an add-on maintenance treatment for severe asthma with eosinophilic inflammation.

The Pulmonary Allergy Drugs Advisory Committee voted unanimously (14 yes, 0 no) that the efficacy and safety data for mepolizumab, an anti IL-5 monoclonal antibody delivered as a 100mg fixed dose via a subcutaneous injection every four weeks, supported approval in adults 18 years of age and older with severe asthma. The Committee also voted that the efficacy data provided substantial evidence of a clinically meaningful benefit in this population (14 yes, 0 no) and safety in adults with severe asthma had been adequately demonstrated (13 yes, 1 no).

But votes against use in younger patients due to limited data

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