EU CHMP recommends approval of Nucala (mepolizumab) for eosinophilic asthma- GlaxoSmithKline

GlaxoSmithKline announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for mepolizumab, which will be commercialised under the brand name Nucala, as an add-on treatment for severe refractory eosinophilic asthma in adult patients. This decision is based on the results from the clinical study programme, which identified the patients that may be suitable for treatment with mepolizumab. Severe refractory eosinophilic asthma patients who participated in the Phase III trials were evaluated by eosinophil level and either a history of recurrent exacerbations or dependency on systemic corticosteroids. All patients were on high-dose inhaled corticosteroids plus another maintenance treatment.

Mepolizumab is not currently approved for use anywhere in the world. Regulatory applications in a number of other countries, including the USA and Japan, have been submitted and are under review. Further submissions are planned during the course of 2015 and 2016.

Comment: Roche has an asthma biologic in late-stage development which is lebrikizumab. Data presented earlier in 2015 at the American Academy of Allergy, Asthma and Immunology meeting suggested that the product's effect on asthma attacks in severe asthmatics who expressed high levels of the protein periostin may have been "unprecedented" in two Phase IIb trials. The only drug approved for severe/allergic asthma is Xolair (omalizumab) from Novartis/Genentech. Teva said its asthma biologic reslizumab, also designed to inhibit IL-5, would be ready for filing in the first half of 2015 based on positive results for two Phase III trials.