Migraine researchers and clinicians are growing excited about a new class of drugs called Calcitonin Gene-Related Peptide (CGRP) monoclonal antibodies, which are showing promise in treating high-frequency episodic migraine and chronic migraine.
"This development is a transformative moment in migraine treatment," said Peter J. Goadsby, MD, PhD, who is chair of the scientific program of the American Headache Society's annual Scientific Meeting. Dr. Goadsby is Chief of the UCSF Headache Center, and one of the world's leading headache treatment experts and researchers.
"There's no question that we need something better," he said. "In fact, for prevention we really need something designed specifically for migraine," he said, noting that there has not been a new class of anti-migraine drugs since the development and marketing of triptans in 1991 and they are not preventives, just designed to treat migraine attacks.
"Up till now, migraine patients have had limited choices for preventive treatment. Now four pharmaceutical companies are showing positive results in human trials targeting CGRP mechanisms," he said. Scholarly papers on CGRP and on the trials are being presented this week at the meeting, which draws more than 1,000 migraine specialists from around the world.
The new class of therapeutic agents appears to reduce elevated levels of the peptide known as calcitonin gene-related peptide (CGRP), a key driver of migraine pain. Versions of anti-CGRP therapies are being tested by Alder Pharmaceuticals, Amgen, Eli Lilly and Company, and Teva Pharmaceuticals.
In Phase IIb trials (studies conducted patients with migraine) data presented at the American Headache Society meeting by Teva reported for the first time that its drug, as a preventive treatment of high frequency episodic migraine, achieved a significant reduction in the number of headache hours after one week, with more than half of patients in each arm experiencing a 50% or greater reduction in headache frequency. Lilly presented, for the first time, Phase II data in episodic migraine that establishes the efficacy of their medicine against placebo with monthly administration across a range of doses. Amgen presented Phase II data for its anti-CGRP product that showed that the drug reduced the number of migraine days by 50% in about half the treated patients after 12 weeks. Alder Pharmaceutical, the fourth player in the CGRP race, is also developing an anti-CGRP drug with positive phase II data published, and did not present further data at the meeting.
"The potential of these new compounds is enormous and gives us real hope that effective specific treatments for migraine may be on the near horizon," Dr. Goadsby said. "The development of CGRP antibodies offers the simple, yet elegant and long awaited option for migraine patients to finally be treated with migraine preventives; it's a truly landmark development."
More than 36 million Americans suffer from migraine attacks, more than have asthma or diabetes combined. About four million have Chronic Migraine or experience more than 15 migraine days a month. High-Frequency Episodic Migraine is defined as 10-14 headache days per month, while episodic migraine (EM) is characterized by those with migraine who have 0 to 14 headache days per month. Migraine can be extremely disabling and costly, accounting for more than $20 billion in direct (e.g. doctor visits, medications) and indirect (e.g. missed work, lost productivity) expenses each year in the United States.
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