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FDA approves GlaxoSmithKline’s Trelegy for treating asthma

Published on 10/09/20 at 01:21pm
Photo by the CDC/FDA

The FDA has approved a new indication of Trelegy Ellipta for the treatment of asthma and patients with chronic obstructive pulmonary disease. 

This was based on a supplemental new drug application which showed that Trelegy provided significant improvements in lung function for patients with these conditions. 

Hal Barron, Chief Scientific Officer at GSK, said: “Millions of asthma patients in the US rely on multiple inhalers to help control their condition and manage their symptoms. Today's approval is an important advance for these patients as it allows them to benefit from triple therapy by using one inhaler, once a day.”

Trelegy is a combination of three molecules in a single inhaler that needs to be taken once per day. It was originally approved by the FDA in 2017 for long-term maintenance patients suffering from chronic obstructive pulmonary disease who are receiving Breo, another inhaler, and require additional bronchodilation or who are receiving Breo and Incruse.

GSK submitted the application to the FDA back in October, and offered data from its Phase 3 CAPTAIN study to prove its effectiveness. This included 2,436 adult patients across 15 countries.

Asthma currently affects 358 million people around the world, with more than half of patients continuing to experience significant symptoms that impact their daily lives.

Conor Kavanagh

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