FDA’s criteria for permitting extrapolation of adult data to a pediatric population created some discomfort at the advisory panel for GlaxoSmithKline PLC’s Breo Ellipta, which is seeking an expanded indication for use in asthma in patients 12 years of age and older.
A dual panel of FDA’s Pulmonary-Allergy Drugs and Drug Safety and Risk Management advisory committees voted March 19 in favor of expanding Breo Ellipta’s (fluticasone furoate/vilanterol) approval to adults but against an approval in adolescents