Facing a slew of competitors, Amgen and Novartis are marching out new Phase IV results to bolster Aimovig, their first-to-market CGRP inhibitor for migraine prevention.
The results come about a year and a half after the drug was panned by a group of medical experts who convened at UnitedHealth Group’s OptumRx offices, concluding it and two other drugs had no clear benefit over existing treatments. The panel suggested that US insurers impose limits on its use, as well as Teva’s Ajovy and Eli Lilly’s Emgality, all approved in 2018, according to a Reuters report.
But on Monday, Novartis announced that new Phase IV results back Aimovig as a better option than topiramate, a standard of care. The double-blind, double-dummy, head-to-head study — dubbed HER-MES — evaluated 777 adult patients with episodic or chronic migraine. Participants had either never received migraine prevention treatment, or discontinued up to three unsuccessful therapies. Researchers compared the safety and tolerability of Aimovig administered at 70 mg and 140 mg with topiramate, an anticonvulsant, in its highest tolerated dose (between 50 and 100 mg).
According to Novartis, the study met its primary endpoint: less discontinuation in the treatment arm over a 24-week period. The biotech also said more patients in the Aimovig arm experienced a reduction of at least 50% in monthly migraine days (MMDs). Full data will come in a future scientific conference.
“The safety profile in the HER-MES study was generally consistent with those seen in previous Aimovig clinical trials,” Novartis announced.
Aimovig was approved in 2018 for migraine prevention in adults. It targets the CGRP protein, which transmits pain signals to the brain and is thought to have a hand in generating and maintaining migraine-associated headaches. The self-injectable drug is meant to be administered once a month.
Novartis and Amgen are co-commercializing Aimovig in the US, while Amgen holds exclusive rights in Japan and Novartis markets it to the rest of the world. Last April, Amgen spurred a legal battle, accusing Novartis of breaching their collaboration deal when subsidiary Sandoz signed a deal to manufacture a rival drug at Alder. Novartis fought back, alleging that Amgen was looking to keep the whole chunk of change for itself. Aimovig’s last quarter sales totaled $105 million.
Migraine is the third most prevalent illness in the world, according to the Migraine Research Foundation. It affects nearly 1 in 4 US households, and about a billion people worldwide. Reports and Data predicted this year that the global market for migraine drugs will hit $3.51 billion by 2026.
Lilly’s Emgality netted $91.5 million dollars last quarter, and Teva’s Ajovy raked in $34 million in Q2 (the biotech has yet to release its Q3 results).
However, new oral candidates pose stiff competition to old injectables. AbbVie’s oral prevention candidate atogepant achieved positive Phase III results in July, and Biohaven’s oral two-in-one treatment and prevention drug Nurtec snagged approval in February. Both AbbVie and Biohaven tout their drugs as first of a kind. Nurtec brought home $9.7 million in Q2.
Will the new Aimovig results be enough to secure the pioneer’s place in the market? Novartis certainly hopes so.
“With Aimovig continuing to be the anti-CGRP treatment with the longest safety and efficacy experience, these results further emphasize its potential to provide significant relief from migraine with an infrequent dosing compared with the oral treatment,” Estelle Vester-Blokland, Novartis’ global head of neuroscience medical affairs, said in a statement.
