The first of a new group of drugs meant to prevent migraines, not just treat their symptoms, could be headed for FDA review next year.
Amgen (NASDAQ: AMGN), of Thousand Oaks, CA, said Wednesday that an experimental drug named erenumab succeeded in the second of two Phase 3 trials—a 955-patient study in people with “episodic” migraines, meaning they suffer from migraines up to 14 days per month. Amgen said its drug did a better job than a placebo of reducing the number of days patients get migraines.
Amgen split patients into three groups, giving them either a low or high dose of erenumab, or a placebo, once a month for six months. Patients on the low dose saw their days with migraines decline by an average of 3.2 days per month compared to how they fared at the beginning of the trial. The decline was 3.7 days for those on a high dose, and 1.8 days for patients on a placebo. That tanslates to a reduction of about 1.4 days (for the low dose) and 1.9 days (for the high dose), on average, per month, compared to placebo. Patients enrolled in the study, known as Strive, suffered migraines an average of 8.3 days per month prior to treatment.
The safety profile of the drug, at both doses, was comparable to placebo, Amgen said. The most common side effects were colds, sinusitis, and upper respiratory tract infections.
Amgen didn’t provide any more specifics regarding the data, but did say that more information will be presented at a future medical meeting. The study also included secondary measures, like erenumab’s ability to reduce patients’ average monthly migraine days by at least 50 percent, or lessen patients’ need for acute migraine treatments. Still, Amgen said that given these results, and data from two other large trials, it aims to begin discussions with regulators. The company expects to file for approval of erenumab next year.
Amgen posted positive results from its first Phase 3 trial of erenumab in September. In that study, Amgen tested only a low dose of the drug, however, and tracked patients over three months instead of six.
“We look forward to working with regulatory authorities to pursue approval of erenumab and making this novel migraine prevention treatment available to patients and physicians,” Amgen research chief Sean Harper said in a prepared statement.
Migraines affect millions in the U.S. According to a 2012 national survey by the Centers for Disease Control and Prevention, 14 percent of U.S. adults reported having a migraine or severe headache in the previous three months. Women reported migraines at more than twice the rate of men, 19 percent compared to 9 percent.
According to Amgen, 90 percent of people diagnosed with migraines have episodic migraines. The remaining 10 percent, who have 15 or more migraine days per month, have the “chronic” variety. Currently, the treatments for migraines inculde generic triptan pills, but those only temporarily curb the pain after symptoms start and can lead to rebound headaches, which can cause other problems.
Should it win FDA approval, erenumab would be the first to market among a new class of drugs meant to prevent migraines by blocking calcitonin gene-related peptide (CGRP), which is released by neurons and is thought to boost the transmission of pain. Rival CGRP-blocking drugs from Alder Biopharmaceuticals (NASDAQ: ALDR), Eli Lilly (NASDAQ: LLY), and Teva Pharmaceutical (NYSE: TEVA) are following behind closely. All three companies expect to report Phase 3 results next year, and that data could help differentiate the various drugs.
The dosing frequency, and whether a drug can be self-administered as opposed to given at the hospital, for example, might represent a few ways certain drugs can gain an edge. Alder aims to show that its drug can be dosed just once every three months. Allergan (NASDAQ: AGN) is also in the mix with a CGRP-blocking pill that it acquired from Merck last year, though mid-stage data for that drug aren’t expected until 2018.