Eli Lilly & Co. said it would seek regulatory approval of a migraine drug this year after seeing positive results from late-stage studies, raising hopes for a new class of treatments for the debilitating headaches.
The drug, galcanezumab, met its primary endpoint in three phase 3 studies, showing significant reductions in the number of monthly migraine headache days compared with placebo at both studied doses, the Indianapolis pharmaceutical manufacturer said Friday.
Lilly plans to submit a biologics license application to the Food and Drug Administration in the latter half of this year, and follow up with submissions to other regulatory agencies around the world.
Some 36 million Americans suffer from migraines, intense headaches that, while varying among patients, are often marked by throbbing pain, sensitivity to light and nausea, according to the American Migraine Foundation. Attacks can last for days, sending sufferers -- who are more likely to be women than men -- into a dark rooms until the migraine goes away or treatment can take effect. There currently is no cure for migraines.
Lilly is one of several companies testing a new class of drugs that target a chemical known by its initials, CGRP. Researchers have found that CGRP, which stands for calcitonin gene-related peptide, is involved in the brain's pain-signaling during migraines. CGRP is a small protein found at the ends of nerves and embedded in blood vessels throughout the body; its release helps dilate, or widen, blood vessels and generally signals pain when it is released into the blood or between nerves.
Galcanezumab is a monoclonal antibody designed to bind to and inhibit the activity of CGRP. It is a self-administered injection.
In the studies, Lilly said the most common adverse effects were injection site reactions, including pain, and the safety and tolerability profile was "consistent with findings from previous studies."
Write to Anne Steele at Anne.Steele@wsj.com
(END) Dow Jones Newswires
May 12, 2017 08:58 ET (12:58 GMT)