Eli Lilly said it will submit a Biologics License Application (BLA) to the FDA later this year for its monoclonal antibody (mAb) migraine candidate galcanezumab, on the back of positive data from three Phase III studies. 

Developed to block calcitonin gene-related peptide (CGRP), galcanezumab has been developed as a once-monthly, self-administered injection for preventing migraine. Data from the placebo-controlled Phase III EVOLVE-1, EVOLVE-2, and REGAIN studies showed that treatment with the mAb significantly reduced the numbers of monthly migraine headache days.

The two 6-month EVOLVE studies evaluated two therapeutic doses galcanezumab, administered monthly, in patients with episodic migraines. Data from the studies showed that therapy led to reductions of between 4.2 and 4.7 average monthly migraine days, compared with 2.3 to 2.8 reductions in average migraine headache days per month for the placebo group. Patients in the EVOLVE studies also reported statistically significant improvements in secondary endpoints, including response rates and daily activity measures.

The 3-month REGAIN study evaluated two dose regimens of galcanezumab in patients with chronic migraine and showed that therapy led to a 4.8-day average reduction in monthly migraine headache days, compared with a 2.7-day reduction for placebo patients. Galcanezumab patients in the REGAIN study also reported statistically significant improvements in secondary endpoints, including response rates and measures of daily activities.

“The topline results from these Phase III data are encouraging and reaffirm the potential for galcanezumab to provide a new option for people living with migraine,” said Robert Conley, M.D., Distinguished Lilly Scholar and Lilly global development leader for migraine therapeutics.

Lilly is also evaluating galcanezumab for the treatment of cluster headache and said Phase III trial results are expected next year. Galcanezumab has been granted Fast Track Designation by FDA.

In January, Lilly agreed to buy CoLucid for $960 million, to acquire the latter’s oral 5-hydroxytryptamine (serotonin) receptor 1F (5-HT1F) agonist lasmiditan, which is in late-stage development for acute migraine therapy.

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