CHMP Backs Mepolizumab for Severe Eosinophilic Asthma

Megan Brooks

Disclosures

September 24, 2015

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of mepolizumab (Nucala, GlaxoSmithKline) for add-on maintenance treatment in adults with severe refractory eosinophilic asthma, the company announced today.

Mepolizumab is an investigational humanized monoclonal antibody against interleukin 5 (IL-5). It prevents IL-5 from binding to its receptor on the surface of eosinophils, thereby reducing blood, tissue, and sputum eosinophil levels. It would be given at a dose of 100 mg administered subcutaneously once every 4 weeks.

The safety and efficacy of mepolizumab were demonstrated in two pivotal phase 3 studies involving several hundred patients with severe refractory eosinophilic asthma who received mepolizumab in addition to standard of care. Results showed that add-on mepolizumab led to a statistically significant reduction in asthma exacerbations and oral corticosteroid use.

The overall adverse event profile was similar between those receiving mepolizumab and those receiving standard of care only. The most commonly reported adverse reactions during treatment were headache, injection site reactions, and back pain. Other adverse events include lower respiratory tract infections, urinary tract infections, pharyngitis, nasal congestion, upper area of abdominal pain, eczema, pyrexia, systemic nonallergic administration-related reactions (including rash, flushing, and myalgia), and hypersensitivity reactions. There were no events of anaphylaxis attributed to mepolizumab.

"For these difficult-to-treat patients, there are very limited treatment options," Dave Allen, GSK chief of Respiratory Therapy Area Unit, R&D, said in a company news release. "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."

Mepolizumab is not currently approved in any country. Its approval would be the first for any monoclonal antibody to IL-5 for any indication.

In June, the Pulmonary-Allergy Drugs Advisory Committee of the US Food and Drug Administration unanimously recommended approval of mepolizumab for add-on maintenance treatment in adults with severe eosinophilic asthma. As reported by Medscape Medical News, based on the evidence presented at the meeting, panel member voting member Steve N. Georas, MD, professor of medicine, Division of Pulmonary and Critical Care Medicine, University of Rochester Medical Center, New York, said: "The question I ask myself is if my 16-year-old daughter was a steroid-dependent asthmatic, with a history of multiple exacerbations in the previous year, would I want to treat her with this compound, and the answer in my mind is a definite 'yes.' "

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