FDA approves Breo Ellipta for adults, not children

FDA approved an sNDA on Thursday for Breo Ellipta fluticasone furoate/vilanterol from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Theravance Inc. (NASDAQ:THRX) to treat asthma in adults. The agency issued a complete response letter for the proposed use of Breo Ellipta in children aged 12-17.

In March, FDA's Pulmonary-Allergy Drugs Advisory and Drug Safety and Risk Management Advisory committees voted 16-4 to recommend approval of Breo Ellipta to treat adults with asthma. The committees voted 18-2 against approval in children aged 12-17. Panelists generally agreed with one member's view that Breo Ellipta showed "no obvious superiority and possibly an inferiority" in efficacy compared to fluticasone furoate in that population (see BioCentury Extra, March 19). ...