- April 18, 2018
- Posted by: PharmaScroll
- Category:
- The LIBERTY trial studied patients with episodic migraine who had failed 2 to 4 prior treatments, a uniquely difficult-to-treat population often excluded from migraine prevention trials.
- Patients taking erenumab had nearly three-fold higher odds of having their migraine days cut by half or more compared to placebo.
- Study completion, safety and tolerability were consistent with results seen in the pivotal clinical program – over 97% of those taking erenumab completed the double-blind treatment phase and erenumab showed a placebo-like safety and tolerability profile.
- Data selected by the American Academy of Neurology Science Committee as one of the most noteworthy presentations at this year’s annual meeting.
Novartis announced full results from the Phase IIIb LIBERTY trial of Aimovig (erenumab, AMG 334) in episodic migraine patients who had previously failed two to four preventive treatments, due to lack of efficacy or intolerable side effects. The data, which will be presented at the annual meeting of the American Academy of Neurology (AAN) in Los Angeles, show the potential of investigational erenumab as an effective preventive treatment option for these patients, who have tried several treatment options without gaining relief. Erenumab is the only 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 erenumab 140mg or placebo for 12 weeks. Patients taking erenumab had nearly three-fold higher odds of having their migraine days cut by at least 50%, with more than twice as many patients taking erenumab achieving this reduction compared to placebo (weeks 9-12: 30.3% with erenumab, 13.7% with placebo, p=0.002, odds ratio 2.73).
“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 with the currently available preventive treatment options,” said Prof. Uwe Reuter, Managing Medical Director at Charité Universitätsmedizin. “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.”
In the study, patients taking erenumab also had statistically significant and clinically meaningful improvements from baseline compared to placebo across all secondary endpoints:
- Reduction in monthly migraine days
- Decrease in acute migraine-specific drug use
- 75% or greater reduction in monthly migraine days
- 100% reduction in monthly migraine days
- Improved physical functioning and ability to complete everyday activities as measured by the Migraine Physical Function Impact Diary (MPFID) scales
Over 97% of erenumab patients completed the double-blind phase of the LIBERTY study. There were no adverse events leading to discontinuation of treatment in the erenumab group while 0.8% of those in the placebo group experienced adverse events leading to discontinuation of treatment.
“In LIBERTY, all primary and secondary endpoints were met. These data, combined with the previously reported positive results, further reinforce erenumab’s robust efficacy and safety profile seen across the full spectrum of migraine,” said Danny Bar-Zohar, Global Head of Neuroscience Development at Novartis. “We strive to demonstrate that our novel therapies provide high value to those patients who continue to suffer, despite standard of care and so we are excited to bring this targeted prevention option, and hope, to these patients as soon as we can.”
LIBERTY contributes to an extensive body of evidence, across the spectrum of migraine, in support of the sustained efficacy, safety and tolerability profile of erenumab including four placebo-controlled Phase II and Phase III clinical studies involving more than 3,000 patients, as well as ongoing open-label extension trials up to five years in duration. If approved, erenumab will be administered every four weeks using a self-injection device. Subject to approval, Novartis and Amgen will co-commercialize erenumab in the US. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize in the rest of the world.
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News Source: Novartis Website
Image Source: https://www.dddmag.com/news/2018/01/amgens-aimovig-erenumab-met-all-endpoints-phase-3b-study