GSK's Nucala gets fresh approval in China

GSK announced on Wednesday that the China National Medical Products Administration (NMPA) has granted approval for ‘Nucala’, or mepolizumab, as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older.

The FTSE 100 pharmaceuticals giant said Nucala was the first anti-Interleukin-5 (IL-5) targeting treatment to receive approval for use in China for adult and adolescent patients with severe eosinophilic asthma.

It said asthma is a major public health concern in China, impacting an estimated 46 million adults, with about 6% of them suffering from severe asthma.

Severe asthma poses the most substantial challenges to daily life, increasing the risk of exacerbations requiring hospitalisation and potentially fatal asthma attacks.

In China, 15.5% of individuals with asthma have experienced an exacerbation necessitating hospitalisation in the preceding year.

The guidelines for bronchial asthma prevention and management, as per the 2020 edition from the asthma group of the Chinese Thoracic Society, underscored the unmet needs of Chinese patients with the condition and emphasised the potential benefits of targeted biologic therapy to reduce exacerbations, hospital visits, oral corticosteroid use, and improve asthma control and lung function.

GSK said the approval for the treatment of severe asthma with Nucala in China was grounded in positive data from a phase three trial specifically conducted among Chinese patients.

The results of the trial reinforced existing global data for mepolizumab's efficacy in patients with severe asthma, while the safety profile remained consistent with known information, with no new safety concerns identified among Chinese patients.

It said the approval was part of a comprehensive clinical development program,e that included four key clinical trials - DREAM, MENSA, SIRIUS, and MUSCA - which established the efficacy and safety of mepolizumab in patients with severe asthma displaying an eosinophilic phenotype.

The safety data was derived from pivotal, long-term, and real-world studies.

Notably, it was the second indication for mepolizumab in China, following its approval for use in adults with eosinophilic granulomatosis with polyangiitis (EGPA), who often have comorbid asthma, in 2021.

“We are delighted with this approval, supported by evidence in a Chinese population,” said Kaivan Khavandi, GSK’s senior vice president and global head of respiratory and immunology research and development.

“Millions of people in China with severe eosinophilic asthma can now potentially benefit from the advance in management that Nucala could offer - a testament to GSK's ongoing commitment to redefine respiratory disease management globally.”

At 0834 GMT, shares in GSK were down 0.8% at 1,563.6p.

Reporting by Josh White for Sharecast.com.