Two Food and Drug Administration (FDA) advisory committees have voted 16 to 4 in favor of approving Breo Ellipta for the treatment of asthma in adults aged 18 years and older, according to a Healio news article. The committee members, however, did vote against recommending the use of the mixed-dose combination therapy for adolescents ages 12 to 17 years. Committee members indicated there was not enough evidence to vote for approval in this age group.
The Healio news report notes that members of the Pulmonary-Allergy Drugs Advisory Committee and its Drug Safety Risk Management Advisory Committee were largely in favor of approving the GlaxoSmithKline therapy in adults, though it was voted 13 to 7 in favor of post-marketing safety trials for this patient population.
Before Breo Ellipta can be approved for use in adolescents, committee member Michael Geary White, MD, said more safety data is needed before the committees can consider recommending approval for use in adolescents. White says, “If we don’t get [the safety] data up front, it’s quite unlikely we’ll get it anytime soon. If we don’t look at this up front we may not get this data until we’ve had a large number of unfortunate events.”
Paul Greenberger, MD, the only person to vote for approval of the therapy to treat asthma in adolescents, explains, “I look forward to telling a patient you only need to take one breath, once a day with your inhaler.”
Breo Ellipta is presently approved for the treatment of COPD. The Healio news report indicates that GlaxoSmithKline is seeking approval of FF/VI 100/25 mcg and FF/VI 200/25 mcg once-daily treatment.