On May 12, 2017, Eli Lilly announced the successful Phase III results for its calcitonin gene-related peptide (CGRP) monoclonal antibody, galcanezumab, for the prophylactic treatment of episodic and chronic migraine. Galcanezumab is the second CGRP monoclonal antibody to release a positive set of Phase III data, behind Amgen ’s erenumab, and it looks to be a race between these two companies to see who can file a Biologics License Application (BLA) first and thus secure first-in-class status.
The results of the three Phase III trials were positive. In patients suffering from episodic migraine, galcanezumab reduced the number of migraine headache days by 4.7 days and 4.6 days for doses of 120mg and 240mg, respectively. This was statistically significant compared to the decrease of 2.8 days for those receiving placebo. The data were nearly identical for patients suffering from chronic migraine, with doses of 120mg and 240mg reducing the number of migraine days by 4.6 days and 4.8 days per month, respectively. This was significantly different compared to the 2.8-day reduction seen in placebo groups.
Originally discovered by Eli Lilly, galcanezumab was licensed out to the biotech start-up Arteaus Therapeutics in 2011. However, the drug was bought back by Lilly on the basis of positive mid-stage trial results in January 2014. It is one of four CGRP monoclonal antibodies in the late-stage pipeline for migraine, lagging only slightly behind Amgen’s erenumab, which released Phase III trial results last month, in the prophylactic treatment of episodic migraine. Galcanezumab does however hold an advantage in the chronic migraine market, as it is the only CGRP monoclonal antibody to have completed a Phase III trial.
Over the course of the next six months, Eli Lilly is likely to prepare filing for a BLA for galcanezumab, with an expected Q4 2018 launch. GlobalData expects this to become a second-in-class prophylactic treatment for episodic migraine—behind erenumab—and a first-in-class treatment for chronic migraine. As well as developing galcanezumab, Eli Lilly is looking to file a New Drug Application (NDA) for lasmiditan in 2018 for the treatment of acute migraine, meaning the company likely will secure a solid position in the migraine market.