Amgen Inc. issued the following announcement on April 17.
Just announced full results from the Phase 3b LIBERTY trial of Aimovig™ (erenumab) in episodic migraine patients who had previously failed two to four preventive treatments, due to lack of efficacy or to intolerable side effects.
The data, which will be presented at the 70thAnnual Meeting of the American Academy of Neurology (AAN) in Los Angeles, show the potential of Aimovig as an effective preventive treatment option for these patients, who have tried several treatment options without gaining relief. Aimovig is the only investigational fully human monoclonal antibody under regulatory review that was designed to selectively block the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation. LIBERTY is the first study to investigate a treatment targeting the CGRP pathway specifically in this challenging patient population.
In LIBERTY, 246 patients who had experienced two to four previous preventive treatment failures were randomized to receive monthly subcutaneous injections of either Aimovig 140 mg or placebo for 12 weeks. Patients taking Aimovig had nearly three-fold higher odds of having their migraine days cut by at least 50 percent, with more than twice as many patients taking Aimovig achieving this reduction compared to placebo (weeks 9-12: 30.3 percent with Aimovig, 13.7 percent with placebo, p<0.002, odds ratio 2.73)
"We are encouraged by these new findings, which add to the growing body of clinical evidence supporting potential use of Aimovig across a broad spectrum of patients with migraine, all of whom live with what is considered one of the most disabling diseases," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "These data support the overall efficacy and safety profile we have seen consistently during extensive clinical study of Aimovig, and speak to its potential to help fill treatment gaps in more difficult patient populations whose migraine has not been adequately managed with current therapies."
In the study, patients taking Aimovig also had statistically significant and clinically meaningful improvements from baseline compared to placebo across all secondary endpoints:
Reduction in monthly migraine days
Decrease in monthly acute migraine-specific drug use
75 percent or greater reduction in monthly migraine days
100 percent reduction in monthly migraine days
Improved physical functioning and ability to complete everyday activities as measured by the Migraine Physical Function Impact Diary (MPFID)
Over 97 percent of Aimovig patients completed the double-blind phase of the LIBERTY study. There were no adverse events leading to discontinuation of treatment in the Aimovig group, while 0.8 percent of those in the placebo group experienced adverse events leading to discontinuation of treatment.
"The LIBERTY study distinctively demonstrates the ability of an anti-CGRP receptor antibody to significantly reduce migraine frequency and its associated burden in patients who could not find the relief they need from currently available preventive treatment options," said professor Uwe Reuter, managing medical director at Charité Universitätsmedizin in Berlin. "These compelling data offer new hope of fewer migraine days to those people with migraine who may have cycled through current standard of care unsuccessfully for years due to lack of efficacy and tolerability."
The long-term open label extension phase of the study is ongoing. LIBERTY contributes to an extensive body of evidence, across the spectrum of migraine, in support of the efficacy, safety and tolerability profile of Aimovig. Aimovig has been studied in four placebo-controlled Phase 2 and Phase 3 clinical studies involving more than 3,000 patients and continues to be studied in an ongoing open-label extension for up to five years in duration.
The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of May 17, 2018, for Aimovig and the European Medicines Agency has validated the Marketing Authorization Application (MAA) for Aimovig. If approved, it will be administered once-monthly using a self-injection device. If approved, Amgenand Novartis will co-commercialize Aimovig in the U.S. Amgen has exclusive commercialization rights to the drug in Japan, and Novartis has exclusive rights to commercialize in rest of world.
Original source can be found here.
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