GlaxoSmithKline and Innoviva have announced that the Trelegy Ellipta fluticasone furoate / umeclidinium / vilanterol DPI has been approved by the FDA for the treatment of asthma in adult patients. The approved doses for the treatment of asthma are 100/62.5/25 mcg and 200/62.5/25mcg FF/UMEC/VI.
The FDA approved Trelegy Ellipta for the treatment of COPD in September 2017 and approved expanded use of the inhaler for COPD in April 2018. GSK and Innoviva announced submission of an sNDA for the asthma indication in October 2019.
GSK Chief Scientific Officer and President, R&D, Hal Barron commented, “Millions of asthma patients in the US 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.”
Innoviva CEO Pavel Raifeld said, “In 2017, Trelegy Ellipta was approved in the US 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.”
Read the GSK and Innoviva press release.
