GlaxoSmithKline Plc said on Wednesday the U.S health regulator approved its lung disease drug Trelegy Ellipta for expanded use, making it the first inhaler delivering three drugs at once to be prescribed for uncontrolled asthma in the country.
The approval is a shot in the arm for the British drugmaker, which seeks to make up for sales lost to generic competition for its blockbuster lung drug Advair.
Revenue from GSK's established Seretide and Advair inhaler brands slumped 29% to 1.73 billion pounds ($2.25 billion) in 2019 due to the launch of cheaper versions from rivals.
GSK said the new target population for Trelegy Ellipta amounts to the about 1.7 million adult asthmatics in the United States, who cannot control their asthma despite being on a maintenance therapy. (https://bit.ly/32emXqF)
Existing triple therapies account for only about 1% of the total U.S. asthma market because of the inconvenience of using multiple inhalers with different dosing schedules, GSK said.
"Trelegy would simplify that with a once-daily inhalation from one device," said Andrew Thomas, GSK's vice president of the U.S. respiratory business.
"This builds on the strong foundation we've seen with Trelegy in COPD (chronic obstructive pulmonary disease)."
Trelegy was approved in the United States in 2017 for the once-daily maintenance treatment of patients with a chronic lung disease called COPD.
The inhaler saw sales from COPD patients more than triple to 518 million pounds ($672.99 million) last year. In the European market, it competes with Trimbow by Italy's Chiesi.
In July, AstraZeneca's rival three-drug inhaler Breztri Aerosphere was also approved in the United States as a maintenance treatment for patients with COPD, also known as "smoker's lung".
(Reporting by Ludwig Burger in Frankfurt and Manojna Maddipatla in Bengaluru; Editing by Arun Koyyur)
