GSK, Innoviva win FDA nod for new Trelegy Ellipta indication

GlaxoSmithKline and Innoviva have received the Food and Drug Administration’s clearance for a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol)  for the treatment of asthma in patients aged 18 years and older.

The product already is approved for use in patients with chronic obstructive pulmonary disease.

The FDA-approved strength for both COPD and asthma is fluticasone furoate / umeclidinium / vilanterol 100/62.5/25mcg. There is an additional strength for asthma alone which is fluticasone furoate / umeclidinium / vilanterol 200/62.5/25mcg.

The approval means Trelegy is the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD and is the only single inhaler triple therapy available for patients in a convenient once-daily inhalation in the United States, the company said.

“Millions of asthma patients in the United States 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,” said Hal Barron, chief scientific officer and president R&D, GSK.

“In 2017, Trelegy Ellipta was approved in the United States as the first once-daily single inhaler triple therapy for the treatment of COPD, and it remains the market leader with strong continued growth. Today’s approval in asthma is another successful outcome for our long-standing partnership with GSK and a testament to our commitment to make innovative medicines accessible to patients with respiratory diseases,” said Pavel Raifeld, Innoviva CEO.