FDA News

FDA committees recommend approval of Breo Ellipta for adults with asthma, suggest more research needed for adolescents

GAITHERSBURG, Md. — Two FDA advisory committees today voted 16-4 in favor of approving Breo Ellipta for the treatment of asthma in individuals aged 18 years and older.

However, the committee members voted against recommending use of the mixed-dose combination therapy in adolescents aged 12 to 17 years.

Members of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and its Drug Safety Risk Management Advisory Committee were largely in favor of approving Breo Ellipta [fluticasone furoate (FF) and vilanterol inhalation powder (VI), GlaxoSmithKline] in adults, although they voted 13-7 in favor of post-marketing safety trials for this patient population.

Committee member Geoffrey Rosenthal, MD, of the University of Maryland Medical Center cast one of the dissenting votes.

“There isn’t a button that says ‘meh,’” Rosenthal said. “I just wanted to take another moment and say [the efficacy and safety of this agent in] the older population is probably under-understood, as is the African-American population. There’s a couple of wrinkles for me, so my vote is ‘meh.’”

However, committee members voted almost unanimously against recommending use of the agent for treatment of asthma in individuals aged 12 to 17 years. Committee members indicated there was not enough evidence to vote for approval in this age group.

Committee member Michael Geary White, MD, of Ochsner Health System in Louisiana said more safety data are needed before the committees can consider recommending approval for use in adolescents.

“If we don’t get [the safety] data up front, it’s quite unlikely we’ll get it anytime soon,” White said. “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, of Northwestern University Feinberg School of Medicine gave his rationale as to why he was effectively the only person to vote for approval of Breo Ellipta to treat asthma in adolescents.

“I look forward to telling a patient you only need to take one breath, once a day with your inhaler,” he said.

Breo Ellipta is already approved for the treatment of COPD. GlaxoSmithKline is seeking approval of FF/VI 100/25 mcg and FF/VI 200/25 mcg once-daily treatment.

White was one of 17 committee members who voted in favor of further research into the safety and efficacy of Breo Ellipta in adolescents, with White and two other members emphasizing pre-approval research.

Although the FDA is not required to follow the recommendations of the advisory committees, it often does.

by Ryan McDonald

GAITHERSBURG, Md. — Two FDA advisory committees today voted 16-4 in favor of approving Breo Ellipta for the treatment of asthma in individuals aged 18 years and older.

However, the committee members voted against recommending use of the mixed-dose combination therapy in adolescents aged 12 to 17 years.

Members of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and its Drug Safety Risk Management Advisory Committee were largely in favor of approving Breo Ellipta [fluticasone furoate (FF) and vilanterol inhalation powder (VI), GlaxoSmithKline] in adults, although they voted 13-7 in favor of post-marketing safety trials for this patient population.

Committee member Geoffrey Rosenthal, MD, of the University of Maryland Medical Center cast one of the dissenting votes.

“There isn’t a button that says ‘meh,’” Rosenthal said. “I just wanted to take another moment and say [the efficacy and safety of this agent in] the older population is probably under-understood, as is the African-American population. There’s a couple of wrinkles for me, so my vote is ‘meh.’”

However, committee members voted almost unanimously against recommending use of the agent for treatment of asthma in individuals aged 12 to 17 years. Committee members indicated there was not enough evidence to vote for approval in this age group.

Committee member Michael Geary White, MD, of Ochsner Health System in Louisiana said more safety data are needed before the committees can consider recommending approval for use in adolescents.

“If we don’t get [the safety] data up front, it’s quite unlikely we’ll get it anytime soon,” White said. “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, of Northwestern University Feinberg School of Medicine gave his rationale as to why he was effectively the only person to vote for approval of Breo Ellipta to treat asthma in adolescents.

“I look forward to telling a patient you only need to take one breath, once a day with your inhaler,” he said.

Breo Ellipta is already approved for the treatment of COPD. GlaxoSmithKline is seeking approval of FF/VI 100/25 mcg and FF/VI 200/25 mcg once-daily treatment.

White was one of 17 committee members who voted in favor of further research into the safety and efficacy of Breo Ellipta in adolescents, with White and two other members emphasizing pre-approval research.

Although the FDA is not required to follow the recommendations of the advisory committees, it often does.

by Ryan McDonald