As Advair struggles, GlaxoSmithKline seeks expanded label for blockbuster-to-be Trelegy

GSK is asking the FDA to expand its label for COPD drug Trelegy.

Facing the prospect of generic competition to respiratory superstar Advair—and as the blockbuster's sales falter under pricing pressureGlaxoSmithKline is pushing to grow new drug Trelegy Ellipta by seeking an expanded indication at the FDA. 

Along with partner Innoviva, GSK applied for approval for Trelegy as a maintenance treatment of airflow obstruction and to reduce exacerbations for patients with chronic obstructive pulmonary disease (COPD).

Trelegy Ellipta is the first FDA-approved closed triple drug that puts three COPD drugs in one inhaler: a LABA, a LAMA and a steroid. GSK's drug contains vilanterol, umeclidinium and fluticasone furoate. Before the approval and launch, patients who needed all three drugs had to use more than one inhaler, or an open triple treatment. 

For the submission, the company is touting phase 3 data from a trial dubbed Impact showing the closed triple option was superior to dual combinations on multiple endpoints such as exacerbation rates, lung function and health-related quality of life. 

Trelegy is already approved as a maintenance treatment for COPD patients who are using GSK's Breo and require additional bronchodilation, or for those who are using Breo and Incruse. Analysts have predicted the new drug could grow to $1.5 billion in annual sales as GSK works to position the drug at the forefront of its respiratory franchise.

Meanwhile, GSK reported that Advair sales fell 15% in the third quarter to £743 million ($980 million) due to "continued pricing pressure." Mylan and Teva are among the companies pushing for approval with their generic copycats, though no rivals have reached the market. Teva has launched AirDuo RespiClick and an authorized generic, but the products aren't direct competitors with Advair and therefore are not substitutable.

Trelegy is one in a group of newly approved drugs GSK hopes can help overcome Advair's decline. On the company's third-quarter conference call, GSK CFO Simon Dingemans said Trelegy is a "key addition to the Ellipta portfolio, and one which we believe will be a significant new growth driver for the respiratory business." But he cautioned that it'll take time to build sales as the drug only won its initial FDA nod in September. 

Elsewhere in GSK's portfolio, new shingles vaccine Shingrix picked up approval in October. Dingemans said on the conference call the company thinks "these two new products represent significant innovation that will benefit patients, and we remain confident in their long-term significance for the group."  

Even more recently, a new HIV combo from GSK secured the FDA's backing last week ask the company looks to put pressure on Gilead Sciences in that field. Together, the three launches are a near-term focus for GSK as it looks to overcome struggles elsewhere, CEO Emma Walmsley has told analysts and investors since coming on board earlier this year.