GlaxoSmithKline earns FDA nod for triple-drug combo Trelegy in sought-after asthma patients

With a handy lead in COPD, GlaxoSmithKline's Trelegy Ellipta has been positioned well as the leading triple-drug inhaler on the market. But with a major competitor gaining speed, GSK is looking to pad Trelegy's advantage—and a trailblazing FDA approval in asthma should do the trick.

The FDA on Wednesday gave its thumbs-up to GSK's Trelegy as a maintenance therapy for asthma, making it the first once-daily, triple-drug inhaler approved in that indication, the British drugmaker said in a release. 

The agency based its review on findings from the phase 3 Captain head-to-head study, which showed Trelegy topped GSK's Breo Ellipta, known as Relvar in Europe, at improving lung function after 24 weeks in patients with uncontrollable asthma.

Trelegy secured the nod despite missing the study's secondary endpoint, failing to beating out Breo when it came to reducing the incidence of episodes where symptoms suddenly worsen. The FDA approval did not include label language for  acute bronchospasm relief.

RELATED: GSK chases Trelegy asthma nod with mixed phase 3 results

The once-daily inhaler not only topped the two-drug combo in terms of clinical efficacy, but it will also offer patients a single insurance co-pay in what Andrew Thomas, GSK's vice president of marketing, called "not only a clinical benefit, but a practical financial benefit for those patients." 

GSK has planned a "significant investment" in its marketing efforts to bring Trelegy in front of physicians used to prescribing multiple inhalers for asthma patients, and the company will lean on Trelegy's reputation as the most-prescribed inhaler for COPD in the U.S., Thomas said.

Trelegy raked in $254 million in second-quarter sales for GSK—a 58% increase from the same time period last year. 

RELATED: GlaxoSmithKline eyes novel death-risk reduction update to Trelegy's label, but analysts say the FDA may not be impressed

Meanwhile, GSK has tried to continue padding its lead as the frontrunner triple therapy in COPD, seeking an FDA label expansion to reduce deaths late last month that ultimately fell flat.

An FDA advisory committee voted against recommending Trelegy's use to reduce patients' all-cause mortality after GSK made the case that follow-up data from a pivotal trial showed some benefit. 

That trial, dubbed Impact, showed the triple-drug combo cut the risk of death during and after treatment by 27.7% over Anoro Ellipta, a GSK combo that contains just two of Trelegy's three drugs. A green light would have made Trelegy the first COPD med with such language on its label.