EMA Advisory Committee Recommends GSK’s New Asthma Drug
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)has issued a positive opinion recommending marketing authorization for GlaxoSmithKline’s mepolizumab, which will be commercialized under the brand name Nucala, as an add-on treatment for severe refractory eosinophilic asthma in adult patients.
The marketing authorization application for mepolizumab was submitted to the EMA in November 2014. The CHMP positive opinion is a formal recommendation to grant marketing authorization for mepolizumab. The final decision will be made by the European Commission and is anticipated before the end of 2015. Mepolizumab is not currently approved for use anywhere in the world. Regulatory applications in a number of other countries, including the US and Japan, have been submitted and are under review. Further submissions are planned during the course of 2015 and 2016.
Mepolizumab is an anti-IL 5 monoclonal antibody that is delivered in a 100-mg dose via subcutaneous injection every four weeks,