FDA Approves GlaxoSmithKline’s Single-Inhaler Triple-Therapy for Asthma

The FDA has approved another indication for GlaxoSmithKline’s (GSK) inhaler triple-therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), allowing its use in treating asthma in patients aged 18 and older.

The approval makes Trelegy the first single-inhaler triple-therapy approved for the maintenance treatment of both asthma and chronic obstructive pulmonary disease (COPD). The therapy, which delivers the three molecules via GSK’s Ellipta dry-powder inhaler, received the agency’s approval for treatment of COPD in September 2017.

“Today’s approval is an important advance for [asthma] patients as it allows them to benefit from triple therapy by using one inhaler once a day,” said GSK’s Chief Scientific Officer Hal Barron.