Galcanezumab is a monoclonal antibody, which was approved by the US Food and Drug Administration in 2018 for the preventive treatment of migraine in adults and in the following year for the treatment of episodic cluster headaches in adults
Lilly’s Galcanezumab to be marketed in Mainland China by AffaMed Therapeutics. (Credit: Momoneymoproblemz/Wikimedia Commons)
AffaMed Therapeutics has signed an agreement with Eli Lilly and Company (Lilly) for securing exclusive commercialisation rights for the latter’s migraine drug Galcanezumab once approved in Mainland China.
Last June, Lilly submitted a new drug application to China’s National Medical Products Administration (NMPA) for Galcanezumab to be used as a preventative treatment for episodic migraine in adults.
The agreement will give AffaMed Therapeutics the rights to import, market, promote, distribute, and detail the monoclonal antibody, which preferentially attaches to calcitonin gene-related peptide (CGRP).
AffaMed Therapeutics is a clinical stage biopharmaceutical company based in China. The company said that the deal with Lilly is a critical opportunity for addressing the considerable unmet need and to enhance the quality of life for migraine patients in China.
AffaMed Therapeutics CEO Dayao Zhao said: “We are excited to reach this agreement with Eli Lilly to bring this innovative product to Chinese patients who are suffering from migraine with symptoms that dramatically impair their quality of life.
“This agreement further demonstrates AffaMed’s aspiration to provide innovative treatments to Chinese patients and represents an important milestone in strengthening AffaMed’s neurology pipeline.”
The PERSIST phase 3 trial of Galcanezumab in patients with episodic migraine showed that the least squares (LS) mean reduction from baseline in monthly headache days (MHDs) over three months was substantially more with the Lilly drug compared with placebo.
The objective of the late-stage placebo-controlled study held on patients from China, India, and Russia, is for evaluating the efficacy and safety of Galcanezumab.
The monoclonal antibody was approved by the US Food and Drug Administration (FDA) in 2018 for the preventive treatment of migraine in adults. The following year, it was approved by the US regulator for the treatment of episodic cluster headaches in adults.
Sold as Emgality in the US, Galcanezumab is presently used for patients with migraine across 20 countries.