FDA approves Trelegy Ellipta for new asthma indication

The FDA has approved Trelegy Ellipta, once-daily, single-inhaler triple therapy, for the new indication of treatment of asthma in adults, according to a company announcement.

Trelegy Ellipta (GlaxoSmithKline and Innoviva) is the first single-inhaler triple therapy approved for both asthma and COPD, according to the press release.

The triple therapy combines fluticasone furoate, an inhaled corticosteroid; umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist. Trelegy Ellipta was approved by the FDA in 2017 for long-term, once-daily maintenance treatment in patients with COPD.

The FDA-approved strength for both COPD and asthma is fluticasone furoate 100 mcg, umeclidinium 62.5 mcg and vilanterol 25 mcg. There is an additional strength for asthma alone: fluticasone furoate 200 mcg, umeclidinium 62.5 mcg and vilanterol 25 mcg, according to the release.

The asthma approval was based on a supplemental new drug application that included data from the CAPTAIN study. As Healio previously reported, Trelegy Ellipta demonstrated significant improvement in lung function in patients with uncontrolled asthma on continuous inhaled corticosteroid and LABA therapies.

“Millions of asthma patients in the U.S. rely on multiple inhalers to help control their condition and manage their symptoms,” Hal V. Barron, MD, chief scientific officer and president R&D at GlaxoSmithKline, said in the press release. “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.”