Novartis announces Phase III STRIVE data published in NEJM demonstrating significant and sustained efficacy of erenumab in migraine prevention

From Drug Discovery Today - November 30, 2017

Novartis today announced that the New England Journal of Medicine (NEJM) published positive results from the six-month Phase III STRIVE study evaluating erenumab in the prevention of episodic migraine (defined in STRIVE as 4 to 14 migraine days per month). Erenumab delivered clinically meaningful and statistically significant differences from placebo for all primary and secondary endpoints including those measured by the novel, validated Migraine Physical Function Impact Diary (MPFID). Treatment with erenumab was well tolerated, with a safety profile comparable to placebo. Erenumab is the first and only fully human monoclonal antibody of its kind, designed to specifically block the CGRP receptor, which plays a critical role in migraine activation.

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

Principal Investigator, Peter Goadsby, M.D., Ph.D., FAHS, Director, NIHR-Wellcome Trust Kings Clinical Research Facility and Professor of Neurology at Kings College Hospital, London, shared his view on what the findings could mean for those with migraine, STRIVE is the first fully reported phase III study of the CGRP pathway monoclonal antibodies, and it clearly shows that blocking this pathway can reduce the impact of migraine, Prof. Goadsby said, The results of STRIVE represent a real transition for migraine patients from poorly understood, repurposed treatments, to a specific migraine-designed therapy. STRIVE, as with the monoclonal antibody developments generally, represents an incredibly important step forward for migraine understanding and migraine treatment.

"The results of the STRIVE study add to the evidence for the significant, consistent benefits of erenumab seen across the spectrum of chronic and episodic migraine, including patients who failed on previous preventive treatments, said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer for Novartis. People with migraine are missing out due to this debilitating neurological disease and are in need of safe, tolerable and effective preventive treatments. We are committed to bringing this much-needed treatment option to patients as soon as possible.

Other secondary endpoint results from the study include:

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