First preventive migraine drug in 20 years that halves number of attacks: NEJM

Migraine sufferers have a new hope now after trials showed that drug called Erenumab cuts the number of attacks in half. It has been found that Patients With an episodic migraine taking the drug reported Significant and Meaningful Benefits Over Six Months, With Reduced Monthly Migraine Days and Acute Medication Use.The once-a-month injection, which can be delivered at home, blocks brain molecules linked to a migraine and is the first new preventative therapy in 20 years. The trial results were published in the New England Journal of Medicine.

Fifty percent of patients taking Erenumab(aimovig) 140 mg had their migraine days cut by at least half - nearly three-fold higher odds compared to placebo patients taking aimovig reported reduced physical impairment and improved ability to participate in daily activities based on a novel patient-reported outcomes tool.ninety percent of patients completed the six-month study; data reinforce the safety and tolerability profile of Erenumab consistently seen in the entire clinical program.

Patients reported significant improvements on key measures assessing the impact of migraine on their lives when taking Erenumab, based on the Migraine Physical Function Impact Diary (MPFID) – a novel patient-reported outcomes instrument validated to specifically measure the impact of migraine on physical functioning. Erenumab is the first and only fully human monoclonal antibody designed to specifically block the calcitonin gene-related peptide (CGRP) receptor; CGRP plays a critical role in migraine activation.

"STRIVE is the first fully reported Phase 3 study of the CGRP pathway monoclonal antibodies, and it clearly shows that blocking this pathway can reduce the impact of migraine," said Peter Goadsby, M.D., Ph.D., FAHS, director, NIHR-Wellcome Trust King's Clinical Research Facility and professor of Neurology, King's College Hospital, London.

STRIVE enrolled 955 patients experiencing a mean baseline of 8.3 monthly migraine days, who were randomized to receive either placebo or subcutaneous Aimovig 140 mg or 70 mg once a month, for six months. Patients taking Aimovig at the higher dose experienced a significant 3.7-day reduction in monthly migraine days (3.2-day reduction with 70 mg, 1.8-day reduction with placebo; p<0.001 for both doses versus placebo). Fifty percent of patients taking Aimovig 140 mg had their migraine days cut by 50 percent or greater, representing a significantly higher likelihood of achieving this response compared to placebo (43.3 percent at 70 mg and 26.6 percent with placebo; odds ratios of 2.8 and 2.1 respectively for 140 mg and 70 mg; p<0.001 for both doses versus placebo). All STRIVE endpoints were assessed from baseline to the average of the last three months of the double-blind treatment phase of the study (months 4, 5, 6).

Secondary study endpoints assessed at six months included reduction of at least 50 percent from baseline in mean monthly migraine days, change from baseline in mean monthly acute migraine-specific medication days, and reductions from baseline in both mean impact on everyday activities domain and mean physical impairment domain scores on the Migraine Physical Function Impact Diary (MPFID).

Erenumab is the first and only investigational therapy targeting the CGRP pathway to have received FDA and European Medicines Agency (EMA) regulatory filing acceptance to date.