"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."
ABOUT MIGRAINE
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.