Zinger Key Points
- GSK's Nucala approved in China for CRSwNP, affecting 1/3 of 107 million sinusitis patients; third IL-5 condition indication in the region.
- Phase 3 trial shows Nucala reduces COPD exacerbations; FDA review ongoing with PDUFA date set for May 7, 2025.
On Friday, the China National Medical Products Administration approved GSK plc GSK Nucala (mepolizumab) as an add-on therapy with intranasal corticosteroids for adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
The FDA approved Nucala for the same indication in July 2021. This is the third indication for mepolizumab in China for an IL-5 mediated condition.
It is estimated that about 107 million people in China suffer from chronic sinusitis, about 1/3 of whom have chronic sinusitis with nasal polyps.
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People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pressure, sleep disturbance, and nasal discharge.
CRSwNP is caused by chronic inflammation of the nasal lining, which can cause soft tissue growth, known as nasal polyps, to develop in the sinuses and nasal cavity.
Mepolizumab is already approved in China as an add-on maintenance treatment for adults and adolescents aged 12 years and older with severe eosinophilic asthma as well as for adults with eosinophilic granulomatosis with polyangiitis.
In September, GSK released the headline results of the MATINEE Phase 3 trial evaluating Nucala for chronic obstructive pulmonary disease or smoker's lungs.
The trial met its primary endpoint with adding Nucala to inhaled maintenance therapy, and study results showed a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations versus placebo with patients treated for up to 104 weeks.
In December, the FDA accepted data from the MATINEE study for review to support the regulatory review process for Nucala, an add-on maintenance treatment for chronic obstructive pulmonary disease with an eosinophilic phenotype. The Prescription Drug User Fee Act date is 7 May 2025.
Price Action: GSK stock closed at $33.95 on Thursday.
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