Lilly's New Migraine Drug Shows Positive Results
May 12 2017 - 9:13AM
Dow Jones News
By Anne Steele
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)
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