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Novartis announces data in Neurology reinforcing the real-world and long-term effectiveness and safety of Aimovig® as a preventive treatment across the full spectrum of migraine

April 16, 2020: “Novartis announced that clinical data for Aimovig® (erenumab) was reported in Neurology. The data strengthens the role Aimovig as a preventive migraine treatment and confirms its real-world and long-term safety and efficacy benefit in patients with episodic and chronic migraine.

The data were scheduled to be presented at the 2020 American Academy of Neurology Annual Meeting in Toronto on April 25-May 1, which was cancelled due to the current COVID-19 pandemic.”

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“These newly shared data reinforce Novartis commitment to reimagine migraine care and add to the growing body of real world and long-term evidence demonstrating the efficacy of Aimovig for migraine prevention across the migraine spectrum,” said Estelle Vester-Blokland, Global Head Neuroscience Medical Affairs, Novartis Pharmaceuticals. “Novartis and Amgen are proud to lead the way based on the vast breadth of experience with Aimovig in showing how patients can take their life back from this highly debilitating disease.”

“Migraine is a highly debilitating disease that has a profound and limiting impact on peoples’ lives, including time spent with family and friends, or at work Aimovig, co-marketed in the US by Amgen and Novartis, is the first and only FDA-approved migraine preventive treatment that targets the calcitonin gene-related peptide (CGRP) receptor. It is self-administered once monthly via the SureClick® autoinjector, does not require a loading dose and is easy to use.

Real-world Data
Interim exploratory results from the real-world TELESCOPE study, conducted with 109 patients in Germany, showed that 80% of patients taking Aimovig reported a reduction of migraine intensity and 92% had fewer attacks, with an average reduction of 8 monthly migraine days (MMD). Furthermore, interim results from the real-world PERISCOPE study in 19,740 migraine patients including 91 patients taking Aimovig with an overall mean disease duration of 18 years, also conducted in Germany, showed that 85% of patients taking Aimovig could cope better with daily activities. Importantly, 83% lost fewer days to migraine since starting the treatment.

Long-term Data in Episodic and Chronic Migraine
Results from a 4.5-year interim analysis of the open-label treatment phase of the Phase II clinical trial in patients with episodic migraine showed that long-term treatment with Aimovig resulted in sustained reductions in MMD. Patients with episodic migraine who switched from 70 mg to 140 mg and remained on 140 mg at ≥4 years, had an average of 5.8 fewer MMD compared with study baseline (8.7 MMD).

In a separate subanalysis of patients with chronic migraine and acute medication overuse (AMO) (NCT02066415), long-term treatment with 70 mg and 140 mg Aimovig reduced MMD by 8.9 days and 10 days, respectively, and by 8.2 and 10.8 days in non-AMO patients. These results further support the use of Aimovig for migraine prevention across the migraine spectrum. Final results are expected to be presented at a medical meeting later this year.

Data on Migraine Days and Acute Medication Use
Results from a post-hoc analysis of 428 patients with episodic (STRIVE, NCT02456740) and 457 patients with chronic migraine (NCT02066415) using acute migraine specific medications (AMSM) showed that preventive treatment with Aimovig plus AMSM as needed significantly reduced MMD, AMSM use and disability compared with AMSMs alone.

Further research using real-word data from pharmacy and medical claims databases reinforced the potential benefits of Aimovig over AMSMs. In this retrospective cohort study using data from 43 of 185 patients, more than one-third of those who initiated Aimovig discontinued AMSMs and more than 80% reduced the amount (units) of AMSM used.

About Aimovig (erenumab)
Aimovig is the first EMA, Swissmedic, Australian TGA and FDA-approved migraine prevention treatment designed specifically to block the CGRP-R, which plays a critical role in migraine.” https://www.novartis.com/news/media-releases/novartis-announces-data-neurology-reinforcing-real-world-and-long-term-effectiveness-and-safety-aimovig-preventive-treatment-across-full-spectrum-migraine

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