GSK's hopes for expanded Breo use face safety scrutiny from FDA panel

GlaxoSmithKline CEO Andrew Witty

Last month, GlaxoSmithKline ($GSK) CEO Andrew Witty told reporters that its new, slow-starter lung drugs were finally picking up steam. That's something the company would like to keep going, and an asthma nod for Breo Ellipta could help that happen. But first, GSK will have to get by an advisory committee panel that has some questions about the drug's safety.

Thursday, the FDA's expert panel will convene over whether the COPD drug could actually make asthma symptoms worse--and whether a larger safety trial should be required, either pre- or postapproval. And its advice is likely to weigh heavily into the FDA's upcoming decision on green-lighting the therapy for asthma patients 12 and older.

Until then, panelists will be reviewing briefing materials the agency released Tuesday--and those contain some doubts about the drug. In a memo from the FDA's Office of Pediatric Therapeutics, Deputy Director of Science Anne McMahon notes that Breo doesn't seem to work all that much better than steroids alone in patients 12 to 17, recommending the committee "consider very carefully whether Breo Ellipta has a positive benefit/risk profile in this age group."

Glaxo could certainly use a regulatory boost for Breo, which raked in just $110 million in revenue last year, Bloomberg reports. Analysts predict the treatment will eventually break the blockbuster barrier, but sluggish launches for it and fellow respiratory contender Anoro have worried investors over the past year as aged Advair began to tank.

According to Witty, though, payer coverage for the pair of newcomers has improved dramatically since their rollouts, and he insists Glaxo is well ahead of its biggest competitor on the access front.

But is that enough to keep the Breo's piece of the pie growing? Not necessarily. "What I am not guaranteeing is exactly how that is going to play out for the rest of the year," he said in February.

- get more from Bloomberg
- see the FDA's briefing documents (PDF)

Special Reports: The top 15 companies by 2014 revenue - GlaxoSmithKline | The 10 best-selling drugs of 2013 - Advair/Seretide

Suggested Articles

A few years ago, one of our Fierce editors met a Big Pharma R&D chief for the first time. “You’re the ones with the scary name,” he joked.

Novartis is touting 52-week data for Cosentyx in spondyloarthritis—an indication where Eli Lilly's Taltz recently scored a trailblazing FDA approval.

Bristol Myers Squibb's Zeposia will leverage promising top-line phase 3 data into a possible FDA approval in the lucrative ulcerative colitis market.