GSK's Nucala gets third approval in China

The FTSE 100 pharmaceuticals giant said the therapy, which targets interleukin-5 (IL-5), would serve as an add-on treatment alongside intranasal corticosteroids for patients whose symptoms were inadequately controlled with systemic corticosteroids or surgery.

It said CRSwNP, a condition marked by chronic inflammation and the growth of nasal polyps, affects an estimated 30 million people in China.

The disease is associated with symptoms such as nasal obstruction, loss of smell, sleep disturbances, and breathing difficulties, significantly impacting patients' quality of life.

Around 80% of CRSwNP cases involve type two inflammation, driven by elevated IL-5 levels, which contribute to severe disease and frequent recurrence of nasal polyps despite surgical intervention.

The approval was supported by data from the phase three MERIT trial, which evaluated the efficacy and safety of mepolizumab over 52 weeks in a cohort of patients from China, Japan, and Russia.

GSK said those findings were complemented by results from the global SYNAPSE study, which involved over 400 participants.

Together, the trials demonstrated the effectiveness of mepolizumab in reducing symptoms and improving disease management for patients with type two inflammation.

Nucala's latest indication marked its third approval in China for IL-5-mediated conditions.

The therapy is already authorised for use in severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis.

“We are delighted that Nucala has been approved in China as a treatment for CRSwNP, a chronic condition for which new and effective treatments are needed,” said GSK senior vice-president and global head of respiratory and immunology research and development Kaivan Khavandi.

“Patients now have a non-surgical option available to them and an alternative to repeated exposure to oral corticosteroids.”

At 0849 GMT, shares in GSK were up 0.07% at 1,362.5p.

Reporting by Josh White for Sharecast.com.