New Migraine Drugs Show Promise.
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 are 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 underway. 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 a migraine. These drugs target a chemical, known by its initials CGRP, involved in the brain’s pain signalling 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.
Credit: Jonathan D. Rockoff for The Wall Street Journal, 29 November 2017.
In the Pipeline
Compounds in a new class of migraine drugs that target the chemical CGRP are nearing the market
|Alder expects to report top-line results from its second Phase 3 study in the first half of 2018 and plans to seek approval in the second half of the year.|
|The Food and Drug Administration is reviewing a request for approval, which could come next year.|
|Ubrogepant, for acute treatment, is in phase 3 testing. Atogepant, for prevention, is in phase 2.|
|Lilly has filed for FDA approval, which could come in the second half of 2018.|
|Teva filed for approval in October and aims for approval and launch during the second half of 2018.|
Source: THE WALL STREET JOURNAL