Mixed FDA advisory panel views on GSK's Breo Ellipta

20 March 2015

There was conflicting news yesterday for UK pharma major GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) from a US Food and Drug Administration expert panel review of the companies’ Breo Ellipta (fluticasone furoate/vilanterol [FF/V]).

The joint meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee met regarding the supplemental New Drug Application for Breo Ellipta as a once-daily inhaled treatment for asthma in patients aged 12 years and older.

The FDA Advisory Committee voted that the efficacy and safety data for FF/VI 100/25mcg and 200/25mcg once daily in asthma support approval in adults 18 years of age and older (16 for, 4 against). The Committee voted that the efficacy data provides substantial evidence of a clinically meaningful benefit in adults (18 for, 2 against) and that the safety in this population has been adequately demonstrated (17 for, 3 against).

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