GSK and Innoviva Announce FDA Approval of Trelegy Ellipta for Expanded Indication in Asthma Treatment

GlaxoSmithKline (GSK.US) and Innoviva (INVA.US) recently announced jointly that the U.S. FDA has approved an expanded indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, FF/UMEC/VI) for the maintenance treatment of asthma in patients aged 18 years and older.

Trelegy Ellipta has reportedly received FDA approval for the treatment of chronic obstructive pulmonary disease (COPD), but it is not indicated for the relief of acute bronchospasm.

In the Phase 3 CAPTAIN clinical trial (randomized, double-blind, active-controlled), Trelegy significantly improved lung function compared with the dual therapy of fluticasone furoate/vilanterol. The FDA-approved dosage strength for the treatment of COPD and asthma is fluticasone furoate/umeclidinium/vilanterol 100/62.5/25 μg. Another dosage strength, approved exclusively for the treatment of asthma, is fluticasone furoate/umeclidinium/vilanterol 200/62.5/25 μg.