FDA advisory Committee recommends mepolizumab for treatment of severe/ eosinophilic asthma- GSK

GSK reported that the meeting of the Pulmonary Allergy Drugs Advisory Committee of the FDA has voted unanimously that the efficacy and safety data for mepolizumab (known as Bosatria), an anti IL-5 monoclonal antibody delivered as a 100mg fixed dose via a subcutaneous injection every four weeks, supported approval in adults 18 years of age and older with severe asthma. The Committee also voted that the efficacy data provided substantial evidence of a clinically meaningful benefit in this population and safety in adults with severe asthma had been adequately demonstrated. The Biologics Licence Application for mepolizumab was submitted to the FDA in November 2014 for approval as an add-on maintenance treatment for patients with severe asthma with eosinophilic inflammation, 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.

The company also reported that the Committee has voted against approval of mepolizumab for use in adolescents 12-17 years of age with severe asthma. The Committee voted that the efficacy and safety of mepolizumab had not been adequately demonstrated primarily due to the limited number of patients in the 12-17 age group in the overall database.

Comment: Roche has an asthma biologic in late-stage development which is lebrikizumab. Data presented recently at the American Academy of Allergy, Asthma and Immunology (AAAAI) annual 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 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.