- Amgen and Novartis should know before next June whether their highly anticipated migraine medication is cleared for entry into the U.S. market, further solidifying the drug's lead position among a blossoming class of new headache treatments.
- On Thursday, the Food and Drug Administration accepted the Biologics License Application (BLA) for erenumab, setting a target action date of May 17, 2018. Amgen and Novartis also disclosed the brand name for the drug will potentailly be Aimovig.
- Erenumab works through inhibiting the calcitonin gene-related peptide (CGRP), a type of protein that research has shown plays key roles in vasodilation and pain. Three other drugmakers have CGRP inhibitors in late-stage testing, though all are behind Amgen and Novartis' drug in terms of filing with regulators.
Erenumab's approval would be huge, both for chronic migraine patients as well as its big pharma backers.
Novartis, for instance, gets pretty much all of its neuroscience revenue from the multiple sclerosis treatment Gilenya (fingolimod). Adding a migraine medication — particularly one that targets CGRP — would not only diversify that piece of its business, but would likely make a noticeable difference on total product revenues. The Swiss drugmaker previously said it expects erenumab to reach blockbuster status.
Amgen is in a somewhat similar boat. The company isn't known as a major player in the neuroscience space. While it does have another early-stage migraine drug in AMG 301 and its Phase 3 Alzheimer's program, an FDA green light for either is relatively far off. Erenumab, therefore, offers a chance to diversify.
Perhaps most importantly, though, is that with a prescription drug user fee act date set, erenumab has locked in its place at the head of the CGRP-inhibitor pack. Eli Lilly and Teva are working on their own drugs that targets those proteins, but don't plan on filing them until later this year. Alder BioPharmaceuticals' eptinezumab will meet regulators even later; the company anticipates filing in the back half of 2018.
Building up optimism for an approval is a strong clinical track record for erenumab as well as other CGRP inhibitors. Phase 3 results announced in November showed patients taking the Amgen and Novartis drug experienced, on average, three migraine days per month versus eight days at baseline.
"Migraine is a serious neurological disease that has a substantial economic burden for both patients and the healthcare system, yet it continues to be under recognized and under treated," Sean Harper, Amgen's head of R&D, said in a July 20 statement.
Amgen and its partner initially linked up to develop erenumab back in 2015, but amended the deal in April so that both parties are responsible for commercializing the drug in the U.S. Novartis picked up exclusive rights to sell the would-be product in Canada, while also securing royalty payments on net sales.
Meanwhile, Amgen could reap more than $400 million in milestone payments from the reworked agreement.