Looking to get ahead in a packed migraine market, Amgen touts head-to-head data for Aimovig
A year after Amgen announced its injectable migraine prevention drug Aimovig proved a better option than the widely used treatment topiramate in a head-to-head study, the pharma company is rolling out the full data. But will it be enough to compete in a packed market, including new oral options?
In a Phase IV study conducted by Amgen’s old partner Novartis, migraine patients in the Aimovig arm showed a significantly lower discontinuation rate due to side effects: 10.5% versus 38.9% in the topiramate arm (p<0.001), according to the companies. In addition, 55.4% of patients in the Aimovig arm achieved at least a 50% reduction from baseline in their monthly migraine days, compared to 31.2% in the topiramate group (p<0.001).
The most common side effects in the Aimovig group were fatigue, nausea, disturbance in attention and dizziness. The topiramate group saw similar side effects, in addition to paraesthesia, or a “pins-and-needles” sensation.
“HER-MES is the first study that directly compared the therapeutic effects of an antibody and a small molecule in migraine prevention,” trial investigator Uwe Reuter said in a statement. “The positive outcomes strengthen the efficacy and safety profile of erenumab as a migraine prevention treatment for patients with migraine.”
Aimovig was approved in 2018 for migraine prevention in adults. It targets calcitonin gene-related peptides (CGRP), which transmit pain signals to the brain and are thought to have a hand in generating and maintaining migraine-associated headaches.
While Amgen and Novartis were initially co-commercializing the drug in the US, the Swiss pharma bowed out of the partnership this summer, laying off 186 employees in the process. Novartis continues to collect royalties and pay Amgen for a portion of commercialization costs.
The move came as Aimovig, which was expected to quickly rake in over $1 billion per year, continued to miss expectations. Last year it made $378 million in the US, which is a modest jump from $306 million in 2019, but still short of blockbuster predictions.
That’s likely due in part to a slew of rivals that have entered the space since Aimovig was approved, including nearly identical treatments from Eli Lilly, Allergan and Teva. And while Amgen touts Aimovig as the first CGRP drug to win approval in migraine prevention, new oral products from Biohaven and AbbVie pose stiff competition to those old injectables.
AbbVie entered the commercial battle for migraine prevention back in September, when it landed an OK for its oral CGRP receptor agonist Qulipta. The drug came from AbbVie’s $63 billion buyout of Allergan, and makes the third approved drug in AbbVie’s migraine portfolio.
While AbbVie’s other CGRP drug Ubrelvy was already approved for the acute treatment of migraine, Biohaven pulled ahead in May when it scored an expanded label for Nurtec to cover preventative use.
“Amgen is dedicated to helping the millions of people who live with this debilitating neurological disease get back to what’s important to them while living with more migraine-free days,” said Rob Lenz, senior VP of global development at Amgen.