Amid falling sales of its blockbuster asthma drug, Advair, GlaxoSmithKline (GSK) finds itself struggling to introduce a new contender into the market.
New data from their phase III CAPTAIN trial showed their chronic obstructive pulmonary disorder (COPD) inhaler, Trelegy Ellipta, fell short when it came to treating patients with uncontrollable asthma. While 24 weeks of use resulted in improved lung function compared to a different inhaler, it did not reduce the frequency and severity of exacerbations — sudden episodes of worsened symptoms.
Trelegy contains three drugs — fluticasone furoate, an inhaled corticosteroid; umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta agonist. This combination means that airway inflammation can be kept at bay using only one device, making treatment more convenient for people with COPD.
The 2017 US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals permitted GSK to market Trelegy for the treatment of COPD, but now they’re seeking regulatory green-light for the treatment of severe, uncontrollable asthma. Asthma affects around 5.4 million people in the UK and about 25 million people in the US.
Despite missing the secondary endpoint, Chief Scientific Officer and President of R&D Hal Barron remains optimistic about Trelegy.
“We believe a once-daily single inhaler triple therapy that improves lung function is an advance for patients with uncontrolled asthma since this option is not currently available,” he said in a news release. “We plan to submit these data for regulatory review after the full dataset is available.”
RELATED VITALS: Mylan’s Generic Advair Breathes New Life into Asthma Market
For years, the pharma giant anticipated generics to challenge its formidable drug, but many companies faced regulatory setbacks that delayed product launches. Earlier this year, Mylan debuted its Advair copycat, Wixela Inhub at a 70 percent discount. While some analysts argued that the discount isn’t as great as it seems, human data science group IQVIA reported booming sales for Mylan’s cheaper asthma inhaler just three weeks after its launch.
Once an untouchable leader in the US asthma market, GSK saw US Advair sales drop by 32 percent in 2018, owing to competitive pricing. From two high-profile Senate Finance Committee meetings, both big pharma and pharmacy benefit managers agree that generic drugs are a good and cheap alternative to brand name drugs.
There is no shortage of asthma treatment options for children in the UK. At the start of the year, the EU asthma market welcomed the expanded indication of Flutiform, a dual drug inhaler, for the treatment of asthma in children aged five and over. Flutiform had already been approved by the EMA in 2012 for youth and adults.
Thirty percent of individuals on corticosteroid and long-acting beta agonist combination therapy have uncontrolled asthma, highlighting an unmet clinical need. Another unanswered question is the cause of asthma, which is thought to be a product of genetic and environmental factors. Sanofi and Sema4 teamed up late last year to launch an asthma research program that studies the disease from every angle.