The European Medicines Agency has accepted the regulatory submission for expanded use of GlaxoSmithKline’s Trelegy in adult asthma patients.
Triple respiratory drug Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is already approved in the EU and US for use in chronic obstructive pulmonary disease (COPD) patients, although GSK is now keen to expand its use beyond that indication.
The EMA submission is supported by data from the phase 3 CAPTAIN study of Trelegy in adult asthma patients, whose disease remained inadequately controlled despite treatment with a combination of inhaled corticosteroid and a long-acting β2-agonist.
The study met its primary endpoint of statistically significant improvement in lung function compared to standard treatment. For the key secondary endpoint – reduction in moderate/severe exacerbations – Trelegy did demonstrate an ability to reduce exacerbation, although the results were not statistically significant.
Trelegy is a key drug in GSK’s arsenal, especially in its efforts to revive sales of its respiratory franchise. GSK’s respiratory business has been hit with the loss of patent protection for its COPD blockbuster Seretide/Advair (fluticasone propionate/salmeterol) – Trelegy is GSK’s answer to the increased competition from generic versions of its once blockbuster-level drug.
It seems like GSK’s efforts are beginning to pay off, with its respiratory sales up 9% at constant exchange rates in the last quarter, thanks in large part to the continued growth of Trelegy Ellipta products.
The expansion into asthma is also important as GSK could soon be facing competition in the COPD market from AstraZenenca’s triple therapy Breztri Aerosphere. The drug is already approved in Japan, and is due for regulatory decisions in Europe and the US this year.
If approved in asthma, GSK could see Trelegy’s use expand even further – the condition affects 358 million people worldwide, with 30% of those experiencing inadequate control.
GSK also has another medicine – Nucala – which is approved for use in severe eosinophilic asthma, although the potential Trelegy indication would open up a larger market.
“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,” said Hal Barron, chief scientific officer and president of R&D at GSK.
Trelegy is also under FDA review for asthma in the US, and in Japan, with both review process currently ongoing.