Drugmaker GSK Plc said on Tuesday that Exdensur (depemokimab), an ultra-long-acting biologic to treat respiratory diseases, has received marketing authorisation from the UK's Medicines and Healthcare products Regulatory Agency.
GSK said Exdensur has now been approved in two indications - as an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation, and as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps.
The FTSE 100-listed firm said the approval was based on data from its SWIFT and ANCHOR phase III trials, which showed "sustained efficacy" with a twice-yearly dosing regimen for depemokimab.
Each of the four trials met their primary or co-primary endpoints with "statistically significant and clinically meaningful" results, comparing the addition of depemokimab to standard of care versus standard of care alone.
GSK's Kaivan Khavandi said: "Today's UK approval of Exdensur, the first in the world, has the potential to redefine care for millions of patients. This ultra-long-acting biologic delivers sustained efficacy to reduce asthma exacerbations, keep patients out of hospital and help prevent cumulative lung damage in just two doses a year. This is a step change in respiratory treatment, and we look forward to additional regulatory decisions expected in the US, Japan, EU and China."
Reporting by Iain Gilbert at Sharecast.com