- The Food and Drug Administration has cleared a three-drug inhaler from GlaxoSmithKline for use in adult asthma patients, an approval the company believes will help differentiate its product in the crowded respiratory drug market.
- GSK's Trelegy Ellipta is now the first inhaler of its kind authorized in the U.S. for both the treatment of asthma and COPD, or chronic obstructive pulmonary disease. The COPD approval came almost three years ago, while the asthma approval arrives on the heels of positive data from a large clinical trial called CAPTAIN.
- Nearly 20 million adults in the U.S. have asthma. Though there are more than a dozen approved treatments, the disease remains uncontrolled for about a third of patients, according to Andrew Thomas, vice president for respiratory marketing at GSK. "A product like Trelegy can provide some relief for those patients," he said in an interview ahead of the FDA's decision.
GSK ranks as one of the world's biggest respiratory drugmakers. In the second quarter alone, the U.K. pharma giant recorded close to 1.7 billion British pounds, or roughly $2.2 billion, in respiratory drug sales across its newer and legacy products.
That position isn't unwavering, however. Sales of GSK's top-selling inhaler, Advair, peaked in 2013 and have declined ever since as the market has gotten more competitive. Mylan launched the first generic version of Advair last year.
Trelegy has become a key product for the company as it moves beyond Advair. The inhaler has recently had the greatest amount of growth of all GSK's respiratory drugs — with sales reaching 194 million pounds from April through June, up about 60% from the same period the year prior.
An approval in asthma will likely drive those numbers higher. The breathing condition affects millions of U.S. adults, and has been a sales boon for other treatments. Sanofi and Regeneron, for example, saw sales of their antibody drug Dupixent spike after the FDA cleared it as an add-on maintenance therapy in patients with moderate-to-severe asthma.
Trelegy is a combination of fluticasone furoate, which reduces inflammation, and the drugs vilanterol and umeclidinium, which each help open up the airway.
In the CAPTAIN study, asthma patients who used Trelegy demonstrated significantly improved lung function compared with those given another GSK drug, Breo Ellipta, which combines just fluticasone and vilanterol and is approved to treat asthma and COPD. The study evaluated lung function by looking at FEV1, a metric that measures how much air a patient can force out of their lungs in one second.
According to Thomas, FEV1 improvements like the ones seen in CAPTAIN typically result in reduced asthma symptoms like nighttime awakening, which then can lead to a better quality of life.
"The metric itself wouldn't mean a lot to a patient," he said, "but the improvement in their lung function would definitely be felt."
As Trelegy heads into the packed asthma market, GSK appears optimistic that there's a place for its drug.
Thomas said the company has heard "very positive feedback" from physicians with regard to the lung function data seen in CAPTAIN.
And as for competition, Thomas said GSK doesn't anticipate going directly against biologic drugs, like Dupixent, since those are often "niche" products used in patients who have more asthma attacks or more severe immune responses.
"Those patients," he said, "should always be on an inhaled therapy as well."