FDA reviewers focus on safety of Breo Ellipta

FDA will ask its Pulmonary-Allergy Drugs and Drug Safety and Risk Management advisory committees to vote on whether to recommend a large pre- or post-approval safety trial to evaluate serious asthma outcomes for Breo Ellipta fluticasone furoate/vilanterol from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Theravance Inc. (NASDAQ:THRX). The agency will also ask the committees whether the companies' safety database is enough to support approval of an sNDA for Breo Ellipta as a once-daily maintenance treatment of asthma in patients 12 years of age and older.

The once-daily, fixed-dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting adrenergic receptor beta 2 agonist (LABA) vilanterol administered with the dry powder Ellipta inhaler has an April 30 PDUFA date. ...