FDA approves GSK’s 3-in-1 Trelega Ellipta inhaler

The FDA has approved the triple inhaler developed by GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) to treat chronic obstructive pulmonary disease, the companies reported today.

The Trelega Ellipta dry powder inhaler uses fluticasone furoate, umeclidinium and vilanterol to help adults with COPD manage the condition. It is the first once-daily product approved in the U.S. that combines three active molecules in a single inhaler for COPD patients.

“COPD is a progressive disease that can worsen over time, and represents a significant burden to patients and healthcare systems,” Eric Dube, SVP & head of GSK’s global respiratory franchise, said in prepared remarks. “The approval of Trelegy Ellipta, and the addition of a once-daily single inhaler triple therapy to our portfolio of respiratory medicines, is an important milestone for GSK that builds on our long heritage in this area.”

“This approval represents a significant therapeutic convenience for those appropriate patients already on Breo Ellipta, that require additional bronchodilation or for those patients already on a combination of Breo Ellipta and Incruse Ellipta,” Innoviva CEO Mike Aguiar added. “Trelegy Ellipta is the latest development in our collaboration with GSK and is testament to our ongoing efforts to advance respiratory medicine.”

Last week, a European Medicines Agency panel also recommended approval for the Trelegy Ellipta triple-combination inhaler.

The regulatory approval is a win for CEO Emma Walmsley, who took over GSK’s corner office in April. The triple lung drug could help fill the revenue gap left by declining sales of GSK’s older drug, Advair. Advair is slated to face generic competition within the U.S. next year and the company is looking for ways to make up for it.

Walmsley has said that that respiratory medicines are a priority for the company. Earlier this year, the CEO laid forth a plan to narrow the focus of GSK’s R&D branch to respiratory and HIV/infectious diseases, alongside oncology and immuno-inflammation.

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