Novartis, Amgen set low price for first CGRP migraine drug

Amgen and Novartis have claimed the first approval for a CGRP inhibitor in migraine, getting an FDA green light for their Aimovig product ahead of rival drugs from Eli Lilly, Teva and Alder Biopharma.

In Europe, migraine sufferers will have to wait a little longer for access to the drug, with the EMA due to complete its ongoing review of Aimovig in the next few months.

Aimovig (erenumab) has been cleared by the US regulator as a once-monthly, self-injected preventive treatment for migraines based on data from three clinical trials which showed the drug was able to reduce the number of migraine days in a month compared to placebo.

Around a third of subjects in the clinical trials of Aimovig experienced a 50% reduction or more, reducing the monthly count by a couple of days on average. The drug is expected to be particularly useful for migraine sufferers who struggle to get relief from the current array of therapies, which consists of pain-killing drugs, triptans and repurposed medicines such as the anticonvulsant topiramate or Allergan's Botox.

The two partners say they intend to launch Aimovig within a week, and have given it a list price of $6,900 per year - or $570 per month - which is well below earlier predictions of an $8,000-$10,000 annual price range. Novartis and Amgen seem to have heeded warnings that healthcare payers may baulk at covering the drug if the price was set too high.

US pharmacy benefits manager Express Scripts warned Novartis and Amgen earlier this year that setting a high list price and offering larger rebates to win position on formularies was misguided, not least because it elevates patients’ out-of-pocket expenses, which are based on the list price. The co-pay burden is one of the key targets in President Trump’s blueprint to lower drug prices in the US.

As a migraine treatment Botox costs around $3,500 per year, and analysts predict that the annual price for Aimovig will drop to around $5,000 with rebates and discounts. The premium over older drugs for prevention should be supportable given that some patients have seen their migraines completely disappear with CGRP inhibitors - something that has never been seen before in chronic migraine therapy.

Amgen and Novartis have beaten Lilly's galcanezumab, Teva's fremanezumab and Alder's eptinezumab to market, with first-mover advantage in a market for CGRP drugs that is expected to grow from zero to $4bn or more by 2026.

Lilly and Teva’s drugs are jostling for second place, with Teva hoping for a verdict in the middle of 2018 for fremanezumab thanks to a priority review voucher that could carve six months off the review time. Lilly is expecting the FDA to complete its review of galcanezumab in the third quarter.

Alder’s eptinezumab is a slightly different proposition because it is given by infusion every three months for prevention - while the other three CGRPs are all given by subcutaneously - and its delivery route means it is also being tested as an acute migraine treatment. The biotech is preparing to file for approval in both chronic and episodic migraine before the end of the year.

Further back in development, Allergan is currently leading efforts to bring oral CGRP drugs to market with its ubrogepant candidate, which recently cleared a phase III trial and is due to be filed for approval next year.