Lilly’s galcanezumab meets goals in phase 3 migraine trials, tucking it in behind Amgen, Novartis in race for market

Eli Lilly
The phase 3 data suggest Lilly's galcanezumab works but do little to calm jitters about its commercial prospects.

Eli Lilly has posted positive data from three phase 3 trials of galcanezumab in migraine patients. But while the data show galcanezumab cuts the number of days patients suffer from migraines, they fall well short of delivering a knockout blow to Amgen and Novartis’ rival drug erenumab.

Two of the Lilly trials looked at the effect of galcanezumab in patients with episodic migraines. In one, patients in the two galcanezumab cohorts experienced 4.7 and 4.6 day reductions in the number of monthly migraine headaches, compared to a 2.8 day drop in the placebo arm. The second trial clocked up figures of 4.3 days and 4.2 days in the galcanezumab cohorts and 2.3 days in the placebo group.

Those declines were big enough for the studies to meet their primary endpoints and set Lilly on a path it thinks will lead to a filing for approval in the U.S. in the second half of the year. But whether they are enough to make the product a big seller for Lilly is questionable.

Lilly is far from the only company developing a calcitonin gene-related peptide (CGRP) inhibitor to treat migraines and its data are in the same ballpark as those generated by other candidates, notably Amgen and Novartis’ erenumab. One phase 3 trial of erenumab linked it to reductions in monthly migraines of 3.2 and 3.7 days, depending on the dose, as compared to 1.8 days in the placebo group. At a 1.9 day improvement over placebo, the result for the higher of the two doses of erenumab is similar to the 1.9 and 2.0 day gains seen in the Lilly trials.

The difference between the erenumab and placebo arms in the other Amgen trial was smaller. But at this stage there is little to suggest one drug is significantly more effective than the other, or that either delivers huge improvements to migraine patients. The companies face the prospect of having to differentiate their products from each other and potentially later CGRP arrivals from Alder Therapeutics and Teva, both of which are in late-phase trials. This level of competition has dampened expectations for individual companies in a niche tipped to be worth $6 billion overall.

Lilly is trailing Amgen and Novartis slightly in episodic migraine but, unlike its rivals, it already has data from a phase 3 study in patients with chronic migraines. The data from the chronic migraine trial were nearly identical to those generated in one of the episodic studies. Patients in the two treatment arms experienced reductions of 4.6 and 4.8 days, compared to a decline of 2.8 days in the placebo cohort.