Drug Development

Amgen, Novartis are racing to regulators with positive PhIII migraine data, but rivals are in hot pursuit

It appears that Amgen and its partners at Novartis are on a straight path to a new drug approval for their new migraine drug erenumab. Six weeks after investigators heralded the first Phase III success for this CGRP drug, Amgen announced today that the second late-stage trial was a hit as well.

In this second Phase III researchers tested a 70 mg and 140 mg dose in a trial that recruited a total of 955 patients. Both doses came through, reducing the average number of migraine days suffered by the groups at 3.2 days and 3.7 days, respectively. The placebo arm experienced a 1.8 day reduction in migraine days, starting off with a baseline of 8.3 days per month.

Next stop: The FDA and the EMA, as marketing applications are prepped for next year.

Amgen $AMGN and Novartis $NVS have split up the world for this drug, with Amgen controlling the US and Novartis running the show in Europe. But while they are in the lead in the race with Alder, Eli Lilly, Allergan, and Teva, it’s highly unlikely they’ll be alone for long.

Migraine is a big market, but Amgen and Novartis have been scolded for failing to differentiate their drug substantially from the CGRP pack. The drug blocks the calcitonin-gene-related-peptide receptor, while competing drugs target the ligand. Amgen/Novartis count that as a major advantage, but the jury’s still out on who will come out on top. And if one of these therapies doesn’t stand out, they’re all going to be battling it out on the market at roughly the same time.

Consensus sales estimates for this drug rank it as a blockbuster contender, with $1.3 billion in 2023 sales. But some analysts are getting nervous about how much the competition will bite into that.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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