By Jonathan D. Rockoff
Researchers outlined positive data for two of the most advanced
migraine drugs in development, reinforcing the promise of a new
class of treatment for the debilitating headaches that is getting
closer to going on sale.
The results, published in papers in the New England Journal of
Medicine on Wednesday, were from separate late-stage clinical
trials of drugs being developed by Teva Pharmaceutical Industries
Ltd. and a partnership between Amgen Inc. and Novartis AG.
The companies are in a heated race to win approval of their
injections and provide relief to migraine patients, many of them
women, who have lacked therapies dedicated to preventing the
attacks.
Some 36 million Americans suffer from migraines, intense
headaches often marked by throbbing pain, sensitivity to light and
nausea.
Pain medicines like ibuprofen and naproxen as well as so-called
triptan drugs, now sold in generic versions, are approved to treat
attacks already under way. But to ward off attacks, patients mostly
rely on drugs approved for other uses, like epilepsy or
depression.
The experimental drugs belong to an emerging class of mostly
injectable biologic treatments to prevent migraine. These drugs
target a chemical, known by its initials CGRP, involved in the
brain's pain signaling during migraines.
Several drug companies have been racing to bring CGRP treatments
to market, including Alder BioPharmaceuticals Inc., Allergan PLC
and Eli Lilly & Co. Several companies have already submitted
their compounds to the Food and Drug Administration for approval,
with decisions expected next year.
Analysts predict the market could reach $4 billion or more
depending on how the drugs are priced. The analysts have given a
wide range of potential prices, from $5,000 to $12,000 a year.
In the latest trials, the companies tested their drugs against
placebo, rather than against each other or current migraine
treatments, and looked at slightly different measurements of
effectiveness and in different kinds of migraine patients.
Teva's trial of its compound, known as fremanezumab, studied
1,130 migraine patients to see how many days of headaches patients
had while taking the company's compound either monthly or every
three months.
The improvement in migraine days for subjects getting
fremanezumab exceeded the improvement seen in patients on placebo
by two days, though the placebo patients also saw a benefit,
according to the researchers.
The 955-subject trial for monthly injections of Amgen and
Novartis's drug erenumab examined the reduction in days of
migraines. Patients had a mean of 1.4 or 1.9 fewer migraine days,
depending on the dose taken, compared with subjects getting a
placebo, who also saw an improvement.
"Within probably the second month, I could tell a difference,"
said Theresa Fredeking, a 57-year-old from Winfield, Mo., who was
in the erenumab trial. She doesn't know if she got the drug, but
she thinks so because "my headaches started diminishing" to five or
six days a month from almost daily.
Researchers for both of the company-sponsored trials reported
minimal side effects, mainly pain around the sites of the
injections. One subject receiving quarterly injections of Teva's
drug died during the trial, but researchers said an autopsy
attributed the death to chronic obstructive pulmonary disease.
Andrew Hershey, a neurology professor who directs the Cincinnati
Children's Hospital Medical Center's Headache Center and wrote an
editorial for NEJM about the trials' results, said the moderate
benefits were probably enough to win FDA approval.
He said the new drugs would be a welcome addition to the arsenal
of migraine treatments, especially for patients who don't always
remember take daily pills.
"The more treatment options we have available to us, then the
more things we can try with an individual patient to find the right
sort of personalized treatment for them," said Dr. Hershey, who has
advised several companies developing CGRP drugs on future
adolescent studies.
Some doctors expressed concern that if the companies priced the
drugs too high, patients who could benefit from them would face
restrictions to access from health plans.
"Their modest efficacy does not justify a premium price [or
first-line treatment status] when long-term safety is unknown, and
we have established preventive drugs that are well tolerated," such
as Botox for chronic migraines and blood-pressure drug lisonopril,
said Elizabeth Loder, a Harvard Medical School neurology professor
and member of the neurology department at Brigham & Women's
Hospital in Boston.
(END) Dow Jones Newswires
November 29, 2017 17:45 ET (22:45 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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