• Amgen and Novartis on Thursday secured Food and Drug Administration approval for Aimovig, the first regulatory thumbs up for a new class of migraine treatments called calcetonin gene-related peptide (CGRP) inhibitors.
• Aimovig heads to market with a broad label, cleared for the preventive treatment of migraine in adults. That means it can work in patients with either chronic or episodic migraines. The label also will not carry any significant safety warnings.
• The companies announced a U.S. list price of $6,900 for a year’s supply. But based on the historical effect of rebates and discounts, the drug’s net price will likely register below $6,000. Leerink analyst Geoffrey Porges noted the list price is below the $8,000 to $10,000 Wall Street expected — which may bode well for payer pickup.

Aimovig (erenumab)’s approval doesn’t come as much of a surprise, given how long it’s been since the FDA cleared a novel class of migraine therapies.

The drug also racked up a solid efficacy and safety profile in the clinic. Two late-stage studies of patients with episodic migraine found those who took Aimovig experienced between one and two fewer migraine days per month than those on placebo. A third, mid-stage study of patients with chronic migraine found patients in the Aimovig arm reported two and a half fewer migraine days each month on average compared to the placebo arm.

A small percentage of participants discontinued the trials due to Aimovig treatment, with the most common side effects being injection site reactions and constipation.

More surprising, however, is the price Amgen put on its new product.

Last month, the Institute for Clinical and Economic Review concluded in a report on CGRP drugs that Aimovig’s annual price would need to be $6,600 for it to achieve a $100,000 per quality adjusted life year threshold among patients with chronic migraine (based on a comparison of 140 mg of the drug versus no treatment). In episodic migraine, the report said the price tag would need to be even lower, $3,900, to meet that cost-effectiveness threshold.

The report came on the heels of a draft scoping document, on which Amgen took issue. It argued ICER’s analysis was too focused on the payer perspective, and didn’t account for costs such as those borne when patients miss work because of their migraines.

Yet, the $6,900 wholesale acquisition cost (WAC) generally aligns with ICER’s estimates. That may be a smart move, according to Leerink’s Porges.

Amgen has “avoided the pitfalls of excessive pricing in this kind of high volume indication,” he wrote in a May 18 investor note.

Porges also wrote that calls with key opinion leaders in the migraine space “indicated that there is a warehouse of patients who have already passed through the required step-edit drugs, and are now waiting for the first anti-CGRP agent. As a result we believe Amgen will benefit significantly from its first mover advantage, and ultimately retain 35-40% market share long-term.”

Only one other CGRP drug, Eli Lilly’s galcanezumab, appears poised for an approval in 2018. There are more competitors to be sure, they’re just not as immediately threatening. Teva Pharmaceutical and Alder Biopharmaceuticals have CGRPs in late-stage testing for migraine prevention, but each has pushed back their timelines for submitting approval applications. Allergan also has one of these drugs, ubrogepant, but it’s an oral medication, and under investigation for acute treatment of migraine.

With rival therapies on the horizon, Amgen is already at work building out Aimovig’s label. Mizuho analyst Salim Syed pointed out that, on a May 18 call, the company said it intended to file an supplemental Biologics Licensing Application for a 140 mg dose of the drug. Now, the FDA recommends a single 70 mg dose once a month, though patients can receive two consecutive 70 mg doses if needed.

The plan clears up some confusion surrounding Aimovig’s pricing, which covers a once monthly 70 mg or 140 mg single-use prefilled SureClick autoinjector(s).