GlaxoSmithKline, needing a sales surge, wins FDA nod for $1B-plus prospect Trelegy

Bracing for generic competition to its top-selling Advair, GlaxoSmithKline nabbed an FDA approval for the "closed-triple" COPD therapy Trelegy Ellipta. It's the latest addition to GSK's lung-med lineup—and it's expected to kick in some much-needed blockbuster sales.

The inhaler, which GSK says it will launch in the U.S. "shortly," is the first closed triple option to win an approval in the U.S. The nod will provide patients with "a more convenient dosing profile," according to a Monday note from Evercore ISI analyst Josh Schimmer.

A closed triple therapy puts three COPD meds in one inhaler: a LABA, a LAMA and steroid. GSK's med contains vilanterol, umeclidinium and fluticasone furoate. Before the approval, patients who needed all three drugs had to use more than one inhaler, or an "open-triple" treatment.

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Analysts with Jefferies have predicted GSK's Trelegy Ellipta could grow to peak sales of $1.5 billion, and the additional sales couldn't come at a better time. With new CEO Emma Walmsley at the helm, Glaxo has rolled out big changes—and big cuts—to its product line and R&D organization. Moving forward, the company is focusing on three near-term launches, Trelegy Ellipta among them, executives told analysts on the company's second quarter conference call.

As Advair copycats inch toward the market, Schimmer thinks Glaxo will look to position Trelegy Ellipta at the forefront of its respiratory franchise, which generated nearly $9 billion last year. Multiple would-be Advair rivals are racing toward the market with copycats to the asthma and COPD megablockbuster. Advair accounted for £3.48 billion ($4.71 billion) of Glaxo's 2016 revenues, or more than half of its respiratory sales.

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So far, Glaxo has been able to dodge that generic competition. Teva has launched its AirDuo Respiclick and an authorized generic, but that therapy lacks an FDA approval to treat COPD. Because the label is different, the Teva product can't be directly substituted for the GSK inhaler.

Mylan is among the companies trying to market an Advair generic, but that company ran into trouble with an FDA complete response letter back in March. It's hoping to regroup and launch its generic in 2018.

Glaxo's new FDA approval comes shortly after an FDA panel recommended another product that's carrying big expectations at the London drug giant. The group last week unanimously endorsed Shingrix, a shingles vaccine that market watchers expect will grow into a blockbuster.

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GSK is partnered on Trelegy Ellipta with Theravance Biopharma and Innoviva; the product won backing last week from Europe's gateway drug-assessment group, the Committee for Medicinal Products for Human use.

AstraZeneca and Novartis also have closed triple therapies in their pipelines, according to Schimmer. Chiesi has a twice-daily closed triple inhaler approved in Europe.