Novartis releases full data from pioneering study in migraine prevention

Publication of LIBERTY trial data shows efficacy of Aimovig® where other treatments have failed




Novartis have announced the full publication of data from the LIBERTY study of Aimovig® (erenumab) in episodic migraine patients who had tried and failed two to four prior preventive treatments. Patients treated with Aimovig had significant improvements on all primary and secondary endpoints of the study.

Aimovig has been developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CDRP-R) which plays a critical role in migraine. Professor Uwe Reuter, Managing Medical Director at Charité Universitätsmedizin said “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 need for a migraine prevention treatment

Migraine is a distinct neurological disease, involving the recurrent attacks of moderate to severe head pain, often associated with nausea, vomiting and sensitivity to light, sound and odors. Migraine is associated with personal pain, disability and reduced quality of life, having a limiting impact on an individual’s ability to carry out everyday tasks. It was reported by the World Health Organization to be one of the top 10 causes of years lived with disability for men and women.

Existing preventive therapies have been repurposed from other indications and are often associated with poor tolerability and lack of efficacy. This leads to high discontinuation rates among patients.

According to the Migraine Research Foundation, 90% of people report they cannot work or function with a migraine

Aimovig is currently the only migraine prevention treatment approved in both the European Economic Area and the US designed to specifically block the calcitonin gene related peptide receptor. Aimovig is also approved in Canada, Australia, Switzerland, the UAE and Singapore.

Novartis and Amgen are co-commercializing Aimovig in the US. Amgen has exclusive commercization rights to the drug in Japan and Novartis has exclusive rights to commercialise in the rest of the world.

 

LIBERTY trial findings

LIBERTY is a Phase IIIb, multicentre, randomized 12-week, double-blind, placebo-controlled study evaluating the safety and efficacy of erenumab in patients with episodic migraine. This level of migraine was defined in the trial as having four to 14 migraine days per month at baseline. The patients had also failed two to four prior preventive treatments for migraine.

In the study, 246 participants were randomized to receive erenumab140 mg or placebo during the 12-week double-blind treatment phase. The primary endpoint was the percentage of patients with at least 50 per cent reduction of monthly migraine days from baseline over the last four weeks of the double-blind treatment phase of the study (weeks 9-12).

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Secondary endpoints assessed during the same period included; change from baseline in monthly migraine days, change from baseline in the number of monthly acute migraine-specific medication treatment days, change from baseline in the Migraine Physical Function Impact Diary and impact on everyday activities domain scores.

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

Almost three times as many patients on Aimovig had their migraine days cut by 75% or more

Danny Bar-Zohar, Global Head of Neuroscience Development at Novartis Pharmaceuticals, said of the findings that “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.”

The patients in LIBERRTY, 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. 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.

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