GlaxoSmithKline picks up FDA panel plug for Breo approval

GlaxoSmithKline took its Breo Ellipta program a step forward Wednesday afternoon, winning the endorsement of an FDA committee for approval of the once-daily treatment for patients with COPD. The panel backed the safety and efficacy of the proposed use of the fluticasone furoate (FF)/vilanterol (VI) combo in patients with the breathing condition--which includes chronic bronchitis and emphysema--but none of the votes was a clean sweep.

Nevertheless, the London-based drug giant ($GSK) emerged with the support of a majority of the nonagency experts on the advisory committee, whose advice the FDA often takes but isn't obligated to follow. The agency is scheduled to decide on whether to approve the experimental product by May 12, a date that is also on the radar for Theravance ($THRX), which would collect a 15% royalty on the first $3 billion in annual sales of Breo for its part in advancing the product in a decade-old pact with GSK.

For GSK, Breo is among a slate of next-generation respiratory drugs and offers future growth prospects for what is now the company's largest franchise led by sales of Advair. For what it's worth, Cowen & Co. analysts project sales of Breo (which GSK plans to market as Relvar in Europe) to hit $2 billion by 2018. Bloomberg averaged 5 analyst estimates and came up with $1.3 billion in 2018 sales. If approved, Breo would also be just the second marketed product from South San Francisco-based Theravance, which could use product revenue to climb out of the red. And later this year regulators are expected to weigh approvals of Anoro, another respiratory med from Theravance ($THRX) and GSK.

"We are pleased with the outcome of today's meeting. COPD is a debilitating and progressive disease. Its symptoms are often severe and can have a huge impact on patients' lives," Patrick Vallance, GSK's president of Pharmaceuticals, R&D, said in a statement. "This positive recommendation is a crucial first step towards making BREO ELLIPTA available for appropriate COPD patients across the U.S. We look forward to a final decision from the FDA later this year."

Theravance's stock, which was halted today, rallied on Monday after the FDA released staff briefing documents for today's committee meeting, yet analysts were mixed on whether the agency's statements about the drug could be viewed as an overall positive. Agency staff noted some inconsistancies in efficacy data, and the briefing also highlighted an increased risk of fractures and pneumonia in patients on the drug.

Here's how the Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted today (questions 1-3 as written in an FDA document):

  • Do the efficacy data provide substantial evidence of a clinically meaningful benefit for FF/VI 100/25 mcg once daily for the long-term, maintenance treatment of airflow obstruction in COPD? (12-yes, 1-no)
  • Do the efficacy data provide substantial evidence of a clinically meaningful benefit for FF/VI 100/25 mcg once daily for the reduction of COPD exacerbations? (8 yes, 5 no)
  • Has the safety of FF/VI 100/25 mcg once daily in COPD been adequately demonstrated for the proposed indications? (10-yes, 3-no)
  • On whether efficacy and safety data support approval for the long-term, maintenance treatment of airflow obstruction in COPD--9-yes, 4-no.
  • And on the question of whether there was enough evidence to support use of the drug to reduce COPD exacerbations in patients with a history of exacerbations--9 yes, 4 no.

- here's GSK's release
- check out Bloomberg's article

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.