GSK asthma drug given green light in China

(Sharecast News) - GSK drug Exdensur has been approved in China for the treatment of asthma, the blue chip announced on Monday.

The treatment, an ultra-long-acting biologic, was given the green light by the National Medical Products Administration for patients aged 12 years and older as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype.

Of the estimated 46m people in China with asthma, around 6% experience symptoms that leave them at risk of hospitalisation. People with severe asthma also have a higher likelihood of potentially fatal attacks.

Kaivan Khavandi, global head of respiratory, immunology and information research and development at GSK, called the NPMA's approval an "important advance" for patients.

He continued: "By providing sustained suppression of type 2 inflammation, an underlying driver of exacerbations and disease progression, Exdensur could redefine care in just two doses a year.

"With Exdensur approved in several major markets, we are focused on transforming the treatment paradigm in severe asthma."

Approval was based on data from the SWIFT-1 and SWIFT-2 phase III trials. The studies both showed that the drug depemokimab - which is marketed as Exdensur - resulted in a 58% and 48% reduction in the rate of annualised asthma exacerbations over 52 weeks. The two trials had 382 and 380 participants respectively, all with severe asthma.

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