Eli Lilly said its CGRP inhibitor galcanezumab succeeded in three phase III trials, opening the door to filing a Biologics Licensing Application (BLA) with the FDA for preventing both episodic and chronic migraine in the coming months.
In top-line results from the EVOLVE-1 and EVOLVE-2 trials, the drug bested placebo at reducing monthly migraine days in episodic migraine, and did the same for chronic migraine in the REGAIN trial, the .
"The top-line results from these phase III data are encouraging and reaffirm the potential for galcanezumab to provide a new option for people living with migraine," Robert Conley, MD, global development leader for migraine therapeutics at Lilly, said in a statement.
Calcitonin gene-related peptide (CGRP) levels are elevated during migraine, and acute blockade of the protein or its receptors has anti-migraine effects. Galcanezumab is a humanized monoclonal antibody that targets CGRP proteins, and is formulated as a once-monthly, self-administered subcutaneous injection.
The EVOLVE studies tested two doses of the drug -- 120 mg or 240 mg -- against placebo over a six-month period in episodic migraine patients, who had 4 to 14 headache days per month.
In EVOLVE-1, the drug offered significantly greater reductions in monthly migraine days compared with placebo (4.7 days for 120 mg and 4.6 days for 240 mg versus 2.8 days for placebo, P<0.001).
The case was similar for patients in EVOLVE-2, with a mean reduction of 4.3 days for 120 mg and 4.2 days for 240 mg versus 2.3 days for placebo (P<0.001).
The REGAIN study tested both doses of the drug over three months in patients with chronic migraine, who had at least 15 headache days per month.
Again, the drug offered significantly greater reductions in monthly migraine days than did placebo (4.8 days for 120 mg and 4.6 days for 240 mg versus 2.7 days for placebo, P<0.001).
Lilly said in all three trials, the drug also beat placebo on secondary endpoints including response rates and measures of daily activities.
The company said it will submit a Biologics License Application to FDA in the second half of 2017, followed by submissions to other regulatory agencies around the world.
Other drugs in the CGRP inhibitor class include Amgen's erenumab, Alder's eptinezumab, and Teva's fremanezumab.