China-based AffaMed Therapeutics has announced an agreement with Eli Lilly and Company to obtain sole commercialization rights for galcanezumab in mainland China. The monoclonal antibody, developed by Eli Lilly, selectively binds to the calcitonin gene-related peptide (CGRP) and was approved by the FDA in September 2018 for the preventive treatment of migraines in adults. It was also approved in June 2019 for the treatment of episodic cluster headaches in adults. Galcanezumab is currently used for migraine treatment in 20 countries worldwide.
Clinical Data and Market Potential
Galcanezumab is the first and only medication approved by the US FDA to reduce the number of attacks for episodic cluster headaches. Eli Lilly submitted a new drug application for galcanezumab as a preventative treatment for episodic migraines in adults to the National Medical Products Administration (NMPA) in June 2022. Migraine headaches are a disabling neurologic disease affecting nearly one in every ten Chinese, with an estimated 130 million prevalent cases, of which approximately two-thirds are women. Despite their high prevalence, migraines remain under-recognized and under-treated in China.
Phase III PERSIST Study Results
In the Phase III PERSIST study, a randomized, double-blind, placebo-controlled pivotal trial assessing the efficacy and safety of galcanezumab in patients with episodic migraines in China, India, and Russia, galcanezumab demonstrated significant efficacy. The least squares (LS) mean reduction from baseline in monthly migraine headache days (MHDs) over three months was significantly greater with galcanezumab compared to placebo (-3.81 days vs. -1.99 days; p < 0.0001). Additionally, significantly greater mean proportions of patients with galcanezumab versus placebo achieved ≥ 50%, ≥ 75%, and 100% reductions from baseline in MHDs (all p < 0.0001).
Future Outlook
With this agreement, AffaMed is poised to bring galcanezumab to the Chinese market, addressing a significant unmet need for effective migraine prevention. The partnership underscores AffaMed’s commitment to improving patient outcomes and expanding access to innovative therapies in China.-Fineline Info & Tech
