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news.Novartis and Amgen’s human monoclonal antibody erenumab has succeeded in a phase 3 study by demonstrating significant and sustained efficacy in the prevention of episodic migraine.
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Erenumab delivered clinically meaningful and statistically significant differences from placebo for all primary and secondary endpoints in the study, dubbed Strive.
Erenumab functions by targeting and inhibiting the Calcitonin Gene-Related Peptide (CGRP) receptor, which is considered to play a key role in activation of migraine.
The six-month long trial featured 955 patients who were randomized to receive either subcutaneous erenumab 70mg or 140mg once a month or placebo.
Patients in the erenumab arm, subjected to higher dose of the drug had registered a significant 3.7-day reduction in monthly migraine days from the baseline of 8.3 days.
Half of the patients, who were given erenumab 140mg, had their migraine days reduced by at least half, which marked a significantly higher probability of achieving this response in comparison to placebo treatment.
Patients in the erenumab arm also had lowered physical impairment while improving their ability to take part in daily activities, as measured on the basis of a validated patient-reported outcome tool.
The endpoints of the trial were evaluated from baseline to the average of the last three months.
Overall, erenumab was found to be well tolerated with its safety profile on par with placebo during the trial, and also with the safety data recorded throughout the entire clinical program of the drug.
Novartis drug development global head and chief medical officer Vas Narasimhan said: “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.
“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.”
After securing approval, Novartis and Amgen plan to co-commercialize erenumab in the US. Amgen holds exclusive commercialization rights to the drug in Japan, while Novartis has exclusive rights in remaining parts of the world.
Image: Novartis’ headquarters in Basel, Switzerland. Photo: courtesy of Novartis AG.
