FDA
12th June 2015

FDA Panel Supports Approval of Mepolizumab for Severe Eosinophilic Asthma

Yesterday, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC)  unanimously recommended mepolizumab

FDA Panel Supports Approval of Mepolizumab for Severe Eosinophilic Asthma

Yesterday, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC)  unanimously recommended mepolizumab (Nucala, GlaxoSmithKline) for add-on maintenance treatment of severe eosinophilic asthma in patients aged 18 years or older. The Committee also voted that the efficacy data provided substantial evidence of a clinically meaningful benefit in this population while also having a positive safety profile. Severe eosinophilic asthma is identified by blood eosinophils greater than or equal to 150 cells/microliter at initiation of treatment or blood eosinophils greater than or equal to 300 cells/microliter in the past 12 months. The materials for this meeting can be found HERE

Consequently, the panel voted 10 to 4 against approval of mepolizumab for adolescents aged 12 to 17 years due to the lack of safety and efficacy data in this particular population.

The panel’s decision follows a discussion of data from one dose-ranging dose selection study (MEA112997; study 97) and two pivotal efficacy studies (MEA115588 and 115575; study 88 and study 75). Study 97 was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study that evaluated the effect of mepolizumab on rates of exacerbation in patients with uncontrolled refractory asthma. The primary endpoint was the annualized rate of asthma exacerbations.

Mepolizumab is a humanized monoclonal antibody (IgG1, Kappa, mAb) to human interleukin 5 (IL-5), delivered as a 100mg fixed dose via a subcutaneous injection every four weeks. Mepolizumab prevents IL-5 from binding to the alpha chain of the IL-5 receptor complex that is expressed on the eosinophil cell. This in turn inhibits signaling and over-expression of eosinophils in the peripheral blood and tissues.

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

The FDA is not bound by the Advisory Committee’s recommendation but often follows their advice.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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