Swiss pharma giant Novartis’ (NYSE: NVS) migraine therapy Aimovig (erenumab) was administered for the first time at Guangzhou United Family Hospital, marking its launch in China through the Greater Bay Area (GBA) early access scheme. The University of Hong Kong-Shenzhen Hospital and Chan Xinghai Hospital have also been approved to provide the treatment.
Migraine Context
Migraines, a chronic neurovascular disorder, are the second leading cause of disability globally, per the WHO. In China, prevalence stands at 9.3%, with women affected three times more than men.
Drug Profile
Aimovig, co-developed with Amgen, received its first approval in the US in 2018 and is now marketed in 73 regions. The Phase III DRAGON study in Asian populations, published in 2022, showed 47% of patients experienced ≥50% reduction in monthly migraine days at 12 weeks, outperforming placebo.
Regulatory Path
A formal NMPA approval filing was submitted in April 2024 and is under review. The drug’s introduction to the GBA follows regulations from November 2020 allowing designated medical institutions in nine Guangdong cities to access clinically urgent overseas-approved drugs, including those marketed in Hong Kong and Macau.-Fineline Info & Tech
