Amgen pulls ahead in sprint towards CGRP approval with promising PhIII migraine data

The frontrunner in the race to commercialize CGRP migraine medications just picked up some added momentum. Amgen $AMGN has published promising Phase III data that might lend to its approval, keeping the company — and its partner Novartis — ahead of its many competitors in the crowded space.

The drug, recently coined Aimovig (erenumab), was studied in 955 patients over six months. The company says 50% of those patients reported the high dose (140 mg) of Aimovig cut their migraine days by 50% or greater (compared to 26.6% with the placebo). The drug met its primary and secondary endpoints. The data were published in the New England Journal of Medicine.

This latest study, which the company calls STRIVE, is the latest in a string of trials testing the drug, including four Phase II and Phase III clinical studies involving more than 2,600 patient.

Teva, meanwhile, came up with some impressive Phase III data details of its own for the rival fremanezumab, with 41% of patients on their CGRP drug seeing their migraine days cut in half, compared to 18% on the placebo. The double blast of data underscores the late-stage race to regulators as some big and small players angle for a slice of the new market.

The FDA has already accepted Amgen’s application for Aimovig — handing the company a PDUFA date of May 17 — giving the company a lead on the competition. If approved, Amgen and its partner Novartis will co-commercialize the drug in the US, after Novartis recently bought into key US marketing rights. Amgen has exclusive rights in Japan, and Novartis has exclusive rights to commercialize the drug in the rest of the world.

The field is growing hot, with a lineup of developers positioning their own late-stage products for the last leg of the race.

Earlier this year, Eli Lilly $LLY celebrated its Phase III results for galcanezumab, with a consistent 2-day reduction in monthly migraines. Then Teva published positive Phase III data showing a 2.5-day reduction in migraines with its fremanezumab. Little Alder $ALDR is also planning to join the commercial fight with their drug. And Allergan $AGN has a late-stage program underway for an oral CGRP therapy it in-licensed from Merck in 2015 with a $250 million upfront.

Oh yes, then there’s Biohaven $BHVN, which recently in-licensed a similar drug from Bristol-Myers Squibb and scored a very successful IPO earlier this year.

The data so far indicate several of these new drugs will look alike, and that means payers will likely play them off against each other.

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Skyhawk Therapeutics Waltham, MA
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Elektroki Boston, MA
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Elektroki Boston, MA
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Recursion Pharmaceuticals Salt Lake City, UT

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