GlaxoSmithKline files for US and EU approval of mepolizumab

GlaxoSmithKline has filed for regulatory approval of its new anti-IL5 monoclonal antibody therapy mepolizumab in the EU and US.

The company is seeking approval of the drug as a maintenance treatment for patients with severe eosinophilic asthma, as identified by a blood eosinophil count of at least 150 cells per microlitre at the start of treatment, or 300 cells per microlitre in the past 12 months.

A US Food and Drug Administration biologics licence application and a European Medicines Agency marketing authorisation application have therefore been submitted this week, supported by a robust body of safety and efficacy data from clinical trials.

Regulatory filings in other countries are planned during the course of 2014 and 2015. To date, this compound has not been approved anywhere in the world.

Dave Allen, head of the respiratory therapy area unit at GlaxoSmithKline, said: "Severe asthma can have serious health consequences and for patients with elevated eosinophil levels whose disease remains uncontrolled despite taking medication, there are few treatment options."

During the third quarter of 2014, the company generated a turnover of 5.6 billion pounds, with strong growth recorded in terms of earnings per share during the period.