An Eli Lilly drug developed to stop migraine headaches before they can start hit its main goals in a late-stage clinical trial, the company said Friday. With those results now in hand, the Indianapolis-based drugmaker plans to file for FDA approval of the drug later this year.
Eli Lilly (NYSE: LLY) tested its drug galcanezumab in three Phase 3 clinical trials enrolling patients who experienced episodic and chronic migraine headaches. Patients were randomized to receive either the Lilly drug or a placebo. The injectable drug did not stop migraines from developing entirely. But in the three-month treatment period, Lilly says that patients given its drug experienced fewer headaches per month compared to the group that received a placebo—enough to show statistical significance.
Lilly says its drug beat a placebo at both the 120 mg and the 240 mg doses. The most common adverse events were reactions at the site of the injection.
Migraines affect 38 million people in the U.S., according to the Migraine Research Foundation. A migraine attack can be debilitating, bringing heightened sensitivity to light and sound, as well as a visual disorientation called an aura. Though the aura typically lasts an hour, migraines can last from several hours to several days. Besides the healthcare costs associated with treating migraines, the condition also takes an economic toll. The foundation estimates that lost productivity from migraines costs the U.S. $13 billion annually.
Lilly’s clinical trial results give additional validation for a new approach to migraine treatment. For decades, the first-line migraine drugs treated pain after symptoms start. These drugs, called triptans, reduce inflammation and constrict blood vessels. Lilly’s galcanezumab is part of a new class of drugs that work in a different way, interfering with a protein called calcitonin gene-related peptide (CGRP). This protein, which is released by neurons, is thought to play a role in transmitting pain. By blocking this protein, researchers aim to stop the onset of migraine pain.
A handful of other companies are also testing drugs that block CGRP. Last year, Amgen (NASDAQ: AMGN) reported positive results from two clinical trials testing its CGRP inhibitor, called erenumab. After reporting successful results from its second Phase 3 trial last November, the company said it would start preparing its application for FDA approval, which could make the drug the first in this new class to reach the market. Bothell, WA-based Alder Biopharmaceuticals (NASDAQ: ALDR) last year reported positive results from a mid-stage clinical trial testing its CGRP inhibitor ALD403. Teva Pharmaceutical (NYSE: TEVA) is also evaluating a CGRP-blocking migraine drug, as is Allergan (NYSE: AGN), which two years ago paid $250 million up front to acquire a compound from Merck (NYSE: MRK).
Lilly says it will file for FDA approval of galcanezumab in the second half of the year. The company also plans to present data from its migraine clinical trials at scientific meetings and submit the data to peer-reviewed journals. In addition to studying galcanezumab in migraine, Lilly is evaluating the drug as a treatment for cluster headache. The company expects to report results from the Phase 3 cluster headache study next year.