GSK’s asthma drug gets marketing authorization in Europe

The European Medicines Agency’s Committee for Medicinal Products for Human Use gives its recommendations for marketing authorization to drugs to the European Commission (EC).

The commission is expected to take a final decision by the end of this year.

Mepolizumab, administered through a 100 mg subcutaneous injection every four weeks, is a monoclonal antibody that recognizes Interleukin 5, which stimulates B cell growth and increases immunoglobulin secretion and the number of eosinophils.

It prevents IL-5 from binding to its receptor on the surface of eosinophils.

Under the Phase III clinical development program, GSK investigated the efficacy and safety of mepolizumab in 915 patients with severe asthma who received the drug apart from standard of care.

The company said all patients in studies MEA115588 and MEA115575 had peripheral blood eosinophil levels greater than or equal to 150 cells/µL at the start of treatment or greater than or equal to 300 cells/µL within the last 12 months.

GSK respiratory therapy area unit head Dave Allen said: "For these difficult-to-treat patients there are very limited treatment options. Many struggle to control their asthma even when taking high doses of inhaled therapies and are often reliant on daily oral corticosteroids, which can cause serious long-term side effects.

"This positive opinion brings us a step closer to adding a targeted biologic therapy, specifically developed for patients with severe eosinophilic asthma, to our respiratory portfolio."

The US Food and Drug Administration is anticipated to take its decision on the drug, mepolizumab, by 4 November.

GSK said mepolizumab is not currently approved for use anywhere in the world. Regulatory applications in several other countries, including Japan, are under review.

The company plans to make further submissions during 2015 and 2016.

Image: GlaxoSmithKline headquaters in Brentford, London, England. Photo: courtesy of Maxwell Hamilton.