Alder gears up for migraine showdown with eptinezumab filing

Alder BioPharmaceuticals has filed its migraine drug eptinezumab with the US regulator, the last in a gang of four CGRP-class antibodies developed to treat the condition.

If approved by the FDA eptinezumab looks set for a US launch in early 2020 into a competitive market where Amgen/Novartis’ Aimovig (erenumab), Eli Lilly’s Emgality (galcanezumab), and Teva’s Ajovy (fremanezumab) have already been approved.

While all the other drugs from the calcitonin gene-related peptide (CGRP) class are administered by patients with special injectors, eptinezumab will be given by infusion every quarter in clinics.

This could give a convenience advantage over Aimovig and Emgality, although Teva’s drug can be given quarterly and without the need for a hospital visit.

Nevertheless Alder is also citing clinical data showing a depth and speed of response, and the drug will also be reimbursed differently in the US because of its use in hospital.

The injected drugs are covered by the complicated pharmacy benefit system in the US, while eptinezumab will be funded as a medical benefit.

Alder’s CEO Bob Azelby told NeurologyLive in an interview this week that this approach has been popular with payers as they will only pay for the drug once it has been administered, dodging the higher upfront costs associated with the pharmacy benefit system.

He also suggested that the rapid response from the drug, which starts to prevent migraine within 24 hours because of its 100% bioavailability, is also of interest to payers looking for value for their investment.

The FDA’s review of eptinezumab will take up to 10 months, and while it is difficult to pre-judge how the review will progress there are already concerns among investors about the data published so far.

When results of the PROMISE-1 phase 3 trial were published in 2017, shares in Alder slipped considerably because of a high placebo effect suggesting eptinezumab could struggle to compete against the competition on efficacy.

Matters were made worse when Alder announced former CEO Randy Schatzman was to step down last March following a “mutual decision”– before former Juno Therapeutics executive Bob Azelby took over in June last year.

The timing was poor and led to further speculation about whether eptinezumab will prove to be a commercial hit, causing the company’s share price to slump.

Allergan is also developing an orally administered CGRP drug, atogepant, which is in late stage development and could further increase the competition in the sector if it reaches the market.

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