The new data comes just a month before the FDA is due to deliver its verdict on Novartis and Amgen's marketing application for Aimovig, which is a little ahead of other CGRP drugs in development, a group which includes Eli Lilly's galcanezumab, Teva's fremanezumab and Alder's eptinezumab.
The drugs are expected to be used most for severe chronic migraine patients who can't get relief from the current array of therapies, which consists of pain-killing drugs, triptans and repurposed medicines such as the anticonvulsant topiramate or Allergan's Botox. Sumatriptan and ergotamine help to constrict these blood vessels and thus ease the pain.
"That reduction in migraine frequency can greatly improve a person's quality of life". "More research is now needed to understand who is most likely to benefit from this new treatment".
"This is the first-ever mechanism specific migraine drug designed for prevention", said lead study author Dr. Peter Goadsby, professor of neurology at Kings College London, UK and University of California, San Francisco".
The study involved adults with chronic migraine who had four to fourteen attacks of migraine per month.
The study is the first to test a CGRP drug in this hard patient population, involving 246 patients who had previously experienced two to four treatment failures.
According to investigators, 30.3% of patients who had notched up two to four previous preventive treatment failures demonstrated at least a 50% drop in migraine days after being treated with Aimovig.
Among them, 39 percent had been treated unsuccessfully with two other medications, 38 percent with three medications and 23 percent with four medications. At 12 weeks, participants in the erenumab study arm had 1.6 times greater reduction in MMDs and 1.7 times greater reduction in MSMDs than participants taking placebo. The number of days that the patients needed to stop the attacks of migraine were also significantly reduced in these patients.
Patients experienced a three times more chance of reduced migraine days by 50 percent after being treated with the new drug for three months compared to those who were treated using a placebo. None of the patients who were put on the new drug Erenumab had to discontinue the drug because they experienced side effects. After three months, patients treated with the human antibody were almost three times more likely to have reduced their migraine days by 50 percent or more, than those treated with placebo. The study was supported by Novartis Pharma AG.
Aimovig is now under review on both sides of the Atlantic, with a United States decision expected next month.
The results of the study were presented at the American Academy of Neurology on Tuesday.