Novartis and its partners at Amgen say that their CGRP migraine drug erenumab (AMG 334) came through in a Phase III study, beating a placebo response in cutting the average number of episodes patients experienced each month. And analysts can now start running the numbers again as they slice and dice the data to see if any of the several rivals in this field can do better.
The two pharma giants enrolled 577 migraine sufferers for the pivotal trial, tracking a baseline of 8 migraine days per month. The patients in the drug arm getting a subcutaneous 70 mg dose one monthly saw that drop an average of 2.9 days, which was significantly better than the 1.8-day drop from a placebo.
The pharma partners will now turn to their second Phase III trial, expected to wrap up later this year, which is testing a 70 mg and 140 mg dose over 24 weeks. The new data comes on top of positive data from a big Phase II study released a few days ago.
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. Leerink’s Geoffrey Porges says that Amgen should be first on the market, then things get a little fuzzy. He writes:
These results in episodic migraine (from Amgen) further support the use of calcitonin-gene-related-
peptide (CGRP) inhibitors for migraine prevention, but also highlight the difficulty in differentiating any one drug from the class given the efficacy and tolerability of all reported thus far. The placebo-adjusted monthly migraine day reduction of 1.1 days reported for AMG 334 in ASPIRE compares favorably with the reduction reported in the Alder (ALDR, OP) ALD403 study of 1 days. Teva’s (TEVA, OP) TEV-48125 produced a numerically greater placebo-adjusted monthly migraine day reduction of 2.5 days, but patients came into the study with a much higher baseline migraine frequency of 11.4 days a month compared to eight days in the AMGN study and roughly nine days in the ALDR study. On a percentage basis, AMG 334 produced a 36% reduction (14% placebo-adjusted), ALD403 a 66% reduction (14% placebo-adjusted), and TEV-48125 a 53% reduction (23% placebo-adjusted).
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