FDA Expands GSK’s Trelegy Ellipta Label to Include Asthma

The FDA has approved GlaxoSmithKline’s (GSK) and Innoviva’s Trelegy Ellipta (fluticasone furoate /umeclidinium /vilanterol) as a maintenance treatment for asthma in patients ages 18 years and older whose asthma is uncontrolled with inhaled corticosteroids and long-acting beta agonist therapy.

The supplemental new drug application was based on a phase 3 trial in which the drug demonstrated significant improvements in lung function compared to treatment with fluticasone/vilanterol. The approval makes Trelegy the first single-inhaler, triple-therapy approved for maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD).

Trelegy Ellipta was initially approved in September 2017 for the long-term, once-daily maintenance treatment of patients with COPD.