Race to CGRP migraine drug finish line enters the final straight

Amgen and partner Novartis are looking at getting an FDA decision on their new CGRP inhibitor drug for migraine by May 17 next year, keeping them ahead of rivals Eli Lilly, Teva and Alder Biopharma.

The US regulator has accepted the marketing application for Aimovig (erenumab; AMG 334) and started its review, keeping the drug in the front of the pack ahead of Lilly's galcanezumab, Teva's fremanezumab and Alder's eptinezumab - all of which have phase III data in hand or coming soon.

The start of the FDA review keeps Amgen and Novartis just ahead of fast-follower Lilly, which said in May it intends to file for its drug later this year.

The CGRP inhibitors offer hope to patients with severe chronic migraine who can't get relief from the current array of therapies, which consists of pan-killing drugs, triptans and repurposed medicines such as the anticonvulsant topiramate or Allergan's Botox. Some patients have seen their migraines completely eradicated with the new drugs - something that has never been seen before in chronic migraine therapy.

"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," said Amgen's head of R&D Sean Harper.

"We are pleased to advance Aimovig, our migraine-specific preventive therapy, to help address the unmet need in this community and potentially mitigate the overall burden of this disease for patients who have already tried other therapeutic options."

That unmet need means the CGRP inhibitors could go from a standing start to become a $4.5bn category in seven key markets - the US, France, Germany, Italy, Spain, the UK and Japan - by 2025, and with competition likely to be fierce getting to market first could be a big advantage.

Novartis' head of development Vas Narasimhan said this week that erenumab good efficacy - with high response rates for the number of patients at a 50% reduction in monthly migraine days or a 100% reduction in monthly migraine day at month 15 - will give it a highly competitive profile.

"It also has a placebo-like safety profile that we plan to continue to establish over longer-term studies, and we hope to be first to market both in the US and the EU," he told analysts on the company's second-quarter results call.