Lilly preps galcanezumab for 2017 filing
- Eli Lilly plans to file one of its highly anticipated migraine treatments in the second half of 2017 following strong readouts from a trio of late-stage studies.
- The drug, galcanezumab, inhibits a group of proteins called calcitonin gene-related peptides (CGRPs) that research has shown are linked to severe headaches. Across the EVOLVE-1, EVOLVE-2 and REGAIN Phase 3 studies, patients experiencing episodic or chronic migraines who took the drug had significantly fewer headaches each month than those who were on placebo treatment.
- While the bulk of the migraine drug market still belongs to triptans, a class of vasoconstrictor molecules long-heralded for their ability to diminish headaches after they start, big pharmas have dove deeper into medications targeting CGRPs in recent years. Teva, Amgen and Novartis are just a few examples of that trend.
Lilly has its sights set on becoming a stronger player in the neuroscience space. Developing a treatment for Alzheimer's disease is a large part of that goal, but it's a risky bet — as exemplified by the solanezumab failure.
Pain, conversely, appears more promising, at least in the near term. The company has three late-stage candidates in the space: galcanzeumab, lasmiditan and tanezumab. The first two are in headache, and have strong clinical track records of safety and efficacy.
EVOLVE-1 and EVOLVE-2, for instance, enrolled patients with episodic migraine and tested 120 mg and 240 mg doses of galcanezumab against placebo. By the end of the six-month treatment period, more than 60% of patients in both dosing arms of EVOLVE-1 reported at least a 50% decrease in the average number of days each month in which they had a migraine. A little under 40% of patients taking placebos said they had the same amount of headache reduction.
Participants taking Lilly's drug were also more likely to see their migraines go away completely. In EVOLVE-2, 11.5% of patients on the 120 mg regimen and 13.8% of those on the 240 mg regimen signaled 100% reduction in their monthly migraine days, versus 5.7% in the placebo group.
REGAIN, meanwhile, showed galcanezumab was also effective for treating chronic migraine. The study tested the same two doses of the drug, and found nearly 28% of patients in the experimental arms had at least a 50% reduction in average monthly migraine days. In the placebo arm, 15.4% of patients said their migraine count had been halved. The 120 mg dose did not significantly outperform placebo in reducing average monthly migraine days by 75% and 100%, however.
Together, the three studies enrolled about 2,900 people.
Lilly plans to submit a Biologics License Application to the Food and Drug Administration sometime in the latter half of 2017, according to a June 10 statement. Should the drug gain approval, the positive late-stage readouts will help it compete against a growing crop of CGRP inhibitors.
Earlier this week, Teva announced more strong results from the HALO study of its migraine treatment fremanezumab. The investigational therapy lowered the number of migraine days patients experienced by 41.6%. The Israeli drugmaker is planning a submission for later this year.
Amgen and Novartis have also filed their candidate erenumab for approval in May.
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