FDA

Amgen and Novartis ID the finish line in a wicked scramble for first CGRP migraine drug OK

Amgen and its partners at Novartis are one step closer to fielding a new migraine drug in the US. The pharma giants said Thursday afternoon that the FDA has accepted their application for erenumab, the furthest advanced CGRP therapy which is now navigating toward a May 17 PDUFA date.

The companies have now dubbed the drug Aimovig, with pivotal data from 2,600 patients.

This is likely going to be quite a crowded field, though, with a lineup of developers positioning their own late-stage products for the last leg of the race through the agency. And the data so far indicate that several of these new drugs will look a lot alike.

Sean Harper

Teva recently lined up a 1.5-day advantage for fremanezumab, reducing migraine days by a significant margin over placebo and putting it in a mix of results posted that tends to hover around the 2-day mark. And it has results for monthly and quarterly dosing. Researchers are always quick to protest any trial comparisons that aren’t head-to-head, and patient populations and dosing aren’t an even match in the studies. But payers will also be expected to consider Eli Lilly’s 2-day advantage, or a Phase III outcome for Amgen and Novartis that was quite similar to Alder’s for 70 mg erenumab, the therapy that is the furthest out front. Allergan also has high hopes for its oral therapy in-licensed from Merck for $250 million upfront.

Amgen R&D chief Sean Harper has been frank about how their drug lines up with the competition, without much to separate the leaders. That makes first mover advantage all the more important. Decision Resources has estimated that the CGRP market by itself could swell to $4.5 billion, making this a blockbuster area of contention — unless the sales numbers are overblown.

It’s clear that the two major league players — which reworked their global alliance last April to split the key US sales arena — are already thinking of how they’ll position this drug once it hits the market, provided the FDA follows through with an OK.

“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 Harper.


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