Novartis Releases Real-World, Long-Term Positive Data from Nearly 20,000 Patients on Aimovig for Migraine Prevention

Compiled by Keke

On April 16, Novartis released the latest clinical data on Aimovig (erenumab) for the preventive treatment of migraine, confirming its real-world and long-term safety and therapeutic benefits in patients with episodic and chronic migraine.

The newly released real-world data include interim exploratory results from the TELESCOPE study, which analyzed 109 patients in Germany. The results showed that 80% of patients treated with Aimovig reported a reduction in migraine intensity, 92% experienced a decrease in the frequency of attacks, with an average reduction of 8 monthly migraine days (MMD). Another set of interim results comes from the PERISCOPE study, involving 19,740 migraine patients, including 91 patients with an overall mean disease duration of up to 18 years. The results indicated that 85% of patients treated with Aimovig were better able to manage their daily activities. Importantly, since the initiation of treatment, 83% of patients experienced a reduction in the number of migraine days.

Another source of long-term data comes from a 4.5-year interim analysis of the open-label treatment phase of a Phase 2 clinical trial in patients with episodic and chronic migraine, which demonstrated that long-term treatment with Aimovig resulted in sustained reductions in monthly migraine days (MMDs). In patients with episodic migraine who switched from the 70 mg dose to the 140 mg dose and continued on the 140 mg dose for ≥4 years, the mean number of MMDs decreased to 5.8, compared with 8.7 MMDs at study baseline.

In a separate subanalysis of chronic migraine patients with acute medication overuse (AMO) (NCT02066415), long-term treatment with Aimovig at doses of 70 mg and 140 mg reduced monthly migraine days (MMDs) by 8.9 and 10, respectively, while non-pharmacological treatment reduced MMDs by 8.2 and 10.8. For patients with AMO, these findings further support the use of Aimovig for preventive treatment across the entire migraine spectrum. The final results of this analysis are expected to be presented at a medical conference later this year.

Novartis also announced the results of two studies on migraine days and acute medication use, including the STRIVE study (NCT02456740) involving 428 patients with acute migraine attacks and a post hoc analysis (NCT02066415) of 457 patients with chronic migraine using acute migraine-specific medications (AMSM). The results showed that preventive treatment with Aimovig as needed in combination with AMSM significantly reduced monthly migraine days (MMD), AMSM usage rates, and disability compared to using AMSM alone.

A further retrospective cohort study using real-world data from pharmacy and medical claims databases reinforced the potential advantages of Aimovig over AMSM. The study, which analyzed data from 43 out of 185 patients, found that more than one-third of patients receiving Aimovig discontinued AMSM, and over 80% reduced their unit usage of AMSM.

Estelle Vester-Blokland, Global Head of Neuroscience Medical Affairs at Novartis, stated, “The latest data reinforce Novartis’ commitment to transforming the current landscape of migraine care, with additional real-world, long-term evidence demonstrating the efficacy of Aimovig in preventing migraine across the entire disease spectrum.”

Migraine is a highly debilitating disease that profoundly impacts patients' lives and work. This distinct neurological disorder involves recurrent episodes of moderate to severe headache, typically pulsating or unilateral, accompanied by nausea, vomiting, and sensitivity to light, sound, and odors. According to the World Health Organization, migraine has been one of the top ten causes of disability for many years. However, the condition remains underrecognized and undertreated.

Aimovig, co-marketed by Amgen and Novartis in the United States, is the first and currently only migraine prophylactic agent targeting the calcitonin gene-related peptide (CGRP) receptor approved by the U.S. FDA, as well as the first migraine preventive therapy approved in Europe, Switzerland, Australia, and the United States.

Aimovig has completed multiple large-scale studies evaluating its safety and efficacy in the prevention of migraine, including four pivotal Phase 2 and Phase 3 placebo-controlled clinical trials, as well as one dedicated study in patients with refractory migraine who have experienced treatment failure.

Novartis Releases Latest Data to Maintain Lead with Partner Amgen in CGRP Migraine Prevention SpaceFollowing the approval of Aimovig, Teva’s Ajovy and Lilly’s Emgality subsequently received FDA approval. On April 7, Lundbeck announced the U.S. launch of Vyepti, making it the fourth CGRP-targeted therapy for migraine prevention available in the U.S. market. However, Aimovig has consistently maintained its lead over competitors in terms of both market share and sales. In a report, RBC Capital Markets analyst Brian Abrahams pointed out that as of March, Aimovig held a 49.2% share of the migraine prevention market, while Emgality and Ajovy accounted for 37.9% and 12.8%, respectively. In terms of sales revenue, Aimovig generated $306 million in 2019, compared to $162 million for Emgality and $96 million for Ajovy.

But in this race, Emgality is closely trailing Aimovig. It is reported that Eli Lilly has also initiated a real-world study to gain further insights into the benefits patients derive from using Emgality.

Reference Sources:

1、Novartis, Amgen tout Aimovig's benefits with real-world and long-term data

2、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