Novartis presents first-of-its-kind data at AAN for AimovigTM* (erenumab) in migraine patients that have failed multiple prior preventive treatments
Apr 18, 2018
LIBERTY is the first trial of its kind specifically designed to study patients with episodic migraine who have failed 2 to 4 prior preventive treatments
Over twice as many patients taking erenumab achieved at least a 50% reduction in monthly migraine days compared to placebo Week 121
Migraine is the third most common disease globally, affecting an estimated 1 in 7 people which equates to almost 200,000 attacks each day in the UK alone2
Frimley, UK, April 17, 2018 – Novartis today 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 and/or intolerable side effects1. The data, selected as one of the most noteworthy presentations at this year’s 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 exhausted currently available 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. In LIBERTY, 246 patients who had experienced two to four previous preventive treatment failures were randomised to receive monthly subcutaneous injections of either erenumab 140mg or placebo for 12 weeks. More than twice as many patients taking erenumab achieved at least a 50% reduction in monthly migraine days compared to placebo (weeks 9-12: 30.3% with erenumab, 13.7% with placebo, p<0.002, odds ratio 2.73).
Migraine is the third most common disease globally, affecting an estimated 1 in 7 people which equates to almost 200,000 attacks each day in the UK alone2. The success of available migraine prophylaxis treatments is often limited by inadequate effectiveness, adverse events and poor patient adherence partly as a result of poorly tolerated current treatment options3.
“There has been no real advancement in migraine treatment for the past twenty years and we’re proud to be breaking new ground in neurology for the millions of people in the UK living with the painful and disruptive symptoms of migraine,” said Dr Mark Toms, Chief Scientific Officer at Novartis UK. “Whilst these data further reinforce erenumab’s efficacy and safety profile it also highlights the clear unmet need that exists for targeted migraine prophylactic treatment and we are committed to working closely with the relevant regulatory bodies to make erenumab available to those that need it as soon as possible.”
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.
There are currently no licensed treatment options available designed specifically for migraine prophylaxis. Marketing authorisation applications for erenumab are currently under review by both the FDA and EMA.
*The brand name Aimovig™ has been provisionally approved by the FDA and EMA for the investigational product erenumab (AMG 334), but the product itself has not been approved for sale in any country.
LIBERTY (NCT03096834) is a Phase IIIb, multicenter, randomised 12-week, double-blind, placebo-controlled study evaluating the safety and efficacy of erenumab in patients with episodic migraine (defined in the trial as four to 14 migraine days per month at baseline) who have failed two to four prior preventive treatments for migraine due to lack of efficacy or intolerable safety effects. In the study, 246 participants were randomised to receive erenumab 140mg or placebo during the 12-week double-blind treatment phase. The primary endpoint was the percentage of patients with at least 50% reduction of monthly migraine days from baseline over the last four weeks of the double-blind treatment phase of the study (weeks 9-12)4. The trial includes an ongoing 52 week open-label extension study.
Secondary endpoints assessed during the same time 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 (MPFID) physical impairment and impact on everyday activities domain scores. The MPFID is a scale developed to measure these two domains. It has been validated in line with US Food and Drug Administration Patient Reported Outcomes Guidance5. Percentages of patients with a 75% response rate and 100% response rate to erenumab, and safety and tolerability were also assessed as secondary endpoints.
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.
About erenumab (AMG 334)
Erenumab (AMG 334) is the only treatment specifically designed to prevent migraine by blocking the CGRP receptor, which plays an important role in migraine activation. Erenumab has been studied in several large global, randomised, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention. More than 3,000 patients have participated in our clinical trial programme across the four placebo-controlled Phase II and Phase III clinical studies and their open-label extensions.
Migraine is the third most common disease in the world, causing a wide variety of painful and debilitating symptoms, one of which is a headache2,6. Migraine is more prevalent than diabetes, epilepsy and asthma combined and classified as one of the highest cause of years lived with disability by the World Health Organisation2,7. Despite this, migraine remains undiagnosed and undertreated in at least 50% of patients8. Existing prophylactic treatments repurposed from other indications are often associated with poor tolerability and lack of efficacy, with high discontinuation rates among patients3.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 122,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.
In the UK, Novartis develops, manufactures and markets innovative medicines, devices and diagnostic tests which help improve patient outcomes. Based on four sites across the north and south of England, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis by manufacturing the active pharmaceutical ingredients used worldwide in many medicines. In 2017 Novartis invested almost £30million in R&D and is a leading sponsor of clinical trials in the UK. For more information, please visit www.novartis.co.uk.
Reuter, U et al. Efficacy and safety of erenumab in episodic migraine patients with 2–4 prior preventive treatment failures: Results from the Phase 3b LIBERTY study. Emerging science abstract presented at AAN, 24 April 2018, Los Angeles.