Novartis announced today that the full data from the LIBERTY study of Aimovig® (erenumab) in episodic migraine patients who had tried and failed two to four prior preventive treatments have been published in the Lancet. Patients treated with Aimovig had significant improvements on all primary and secondary endpoints of the study. Aimovig is specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R), which plays a critical role in migraine.
"These findings provide real hope for patients who have been suffering for years with the pain and disability of migraine while cycling through numerous treatment options due to lack of efficacy or intolerable side effects." said Prof. Uwe Reuter, Managing Medical Director at Charité Universitätsmedizin. "These results show efficacy for Aimovig in the patients with the highest unmet medical need, not only in reducing migraine days but also in allowing them to get back to their daily lives."
The LIBERTY data show that, compared to placebo, from baseline to the last month of therapy (weeks 9-12):
- The primary endpoint showed that more than twice as many patients on Aimovig had their migraine days cut by 50% or more (30% vs.14%; odds ratio 2.7, p=0.002)
- Almost three times as many patients on Aimovig had their migraine days cut by 75% or more (12% vs. 4%; odds ratio 3.2, p=0.025, secondary endpoint)
- 6% of patients on Aimovig were completely migraine free (migraine days cut by 100%) vs no patients (0%) on placebo (secondary endpoint)
- Patients on Aimovig experienced a substantial reduction in monthly migraine days (MMD) (1.8 vs 0.2 fewer MMD, p=0.004, secondary endpoint)
- Those in the Aimovig arm reported significant reductions in the number of days per month using acute migraine-specific medication (1.3 reduction vs 0.5 day increase; p<0.001, secondary endpoint)
- Overall, the tolerability and safety profiles for Aimovig were similar to placebo, in keeping with findings throughout the drug's clinical trial program of over 3,000 patients
"The ground-breaking LIBERTY data reinforce Aimovig as a safe and effective preventive treatment option for patients across the spectrum of migraine, including those who live with particularly difficult-to-treat migraine," said Danny Bar-Zohar, Global Head of Neuroscience Development at Novartis Pharmaceuticals. "These patients deserve a preventive treatment option which allows them to be there more at home, at work and with friends. With Aimovig, we are paving the way and reimagining care for these migraine patients who have struggled to find effective preventive therapies."
The patients in LIBERTY, who had tried multiple treatments without success, represent a section of the migraine community which is highly impacted by the disease in all areas of life. Of note, the recent My Migraine Voice study showed that patients with multiple prior treatment failures reported the greatest impact on work productivity compared to those who had not previously tried treatments without success. Moreover, a higher proportion of these patients reported a negative impact on their social and personal life. In LIBERTY, in an additional secondary endpoint, patients treated with Aimovig reported a significantly greater improvement on all outcomes including ability to complete everyday activities, such as chores and getting out of bed, compared to placebo (Migraine Physical Function Impact Diary [MPFID] physical impairment scale, 3.5 point difference, p= 0·003; everyday activities scale, 3.9 point difference, p<0·001).
Aimovig is approved in the European Economic Area, the United States (erenumab-aooe), Canada, Australia, Switzerland, the United Arab Emirates and Singapore.