FDA panel says Glaxo asthma drug isn't proven safe for teens
- A panel of experts who advise the FDA gave GlaxoSmithKline a mixed bag on Thursday, voting to support the asthma inhaler Breo Ellipta's use in adults but rejecting its recommendation for use in teens aged 12 to 17.
- The FDA panel voted 16-4 to support Breo Ellipta for adults but 18-2 against an indication for adolescents. The panel also voted to require GSK to conduct a new, large safety study for both adults and teens.
- While the agency isn't required to follow the advisory panel's recommendations, it usually does—especially in cases where the votes are so lopsided.
As BioPharma Dive has previously reported, asthma drugs containing long-acting beta-adrenoreceptor agonists (LABAs) have always been subject to scrutiny and warnings. Earlier this week, the FDA concluded that the risks presented by the presence of vilanterol in Breo Ellipta were not observed uniformly enough in order to justify the drug's disqualification.
But evidently, there's enough uncertainty in the data that the panel couldn't recommend the inhaler's use in teens. That's a blow to Glaxo, which is grappling with generic competition for its flagship asthma product Advair in Europe and downward pricing pressure from payers in the U.S.
A Glaxo spokesperson said that the company would "continue to work closely with the FDA while it considers the committee's recommendations and our aim is to answer any outstanding questions."