GSK chases Trelegy asthma nod with mixed phase 3 results

With generics attacking Advair, GlaxoSmithKline has talked up prospects for 3-in-1 respiratory med Trelegy. Now, the company has data in hand that could help it move into the asthma arena—though it's not all positive.

Thursday, GSK released phase 3 trial data showing Trelegy had topped Breo Ellipta, known as Relvar in Europe, at improving lung function after 24 weeks in patients with uncontrollable asthma. But Trelegy did not hit the study's secondary endpoint, failing to show significant benefits over Breo when it came to reducing the incidence of episodes where symptoms suddenly worsen. 

Despite those mixed results, GSK thinks Trelegy has what it takes to expand into the asthma field, and it intends to submit the data to regulators. "We believe a once-daily single inhaler triple therapy that improves lung function is an advance for patients with uncontrolled asthma since this option is not currently available," GSK R&D chief Hal Barron said in a statement.

GSK has looked for new avenues for Trelegy—first approved for COPD treatment by the FDA in 2017—and other respiratory players as sales of Advair, a long-time bestseller, have dwindled under aggressive discount demands from payers.

And as of this year, knockoffs are adding to the pain, too. In January, Mylan received its FDA nod for its Advair generic, the first approved for use. In its preparation for launch, Mylan promised a 70% discount on the branded drug’s list price, but analysts said the price cut wasn’t as significant when considering GSK's mammoth Advair discounts.

Those discounts have proved ruinous for Advair’s sales, which saw a 23% decrease on the year in 2018 to £2.4 billion ($3.14 billion). Trelegy, meanwhile, didn't do much to stem the tide, kicking in just £156 million ($205 million) for the year.

Analysts, though, expect that to change. At the time of its approval, Jefferies analysts said Trelegy was poised to pull in around $1.5 billion in peak sales for GSK, and meanwhile, new CEO Emma Walmsley isn't waiting around for help. 

In September 2018, the company axed 650 jobs—including 450 in sales—in a move to shore up funds for its R&D pipeline and new drug launches, including severe eosinophilic asthma treatment Nucala and shingles vaccine Shingrix. At the time, GSK said the cuts were intended to take the focus off the asthma market, but Trelegy’s possible approval in the field could re-open the door.

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