Amgen has chalked up another positive trial for its new migraine candidate erenumab as it vies to beat rivals Teva, Eli Lilly and Alder Biopharmaceuticals to market.
The biotech giant now has two positive Phase III trials in hand for erenumab (AMG 334) in patients with episodic migraine and said it is hoping to file for approval of the calcitonin gene-related peptide (CGRP) inhibitor—developed in partnership with Novartis—early next year.
The latest STRIVE study compared two once-monthly doses of erenumab to placebo and showed that Amgen and Novartis' drug was able to achieve a significant reduction in the number of days patients experienced severe headaches.
At enrollment patients were experiencing an average of around 8 days with migraines per month. Treatment with 70mg or 140mg of erenumab cut that by 3.2 and 3,7 days respectively, while those on placebo experienced a 1.8-day reduction.
Those results are pretty consistent with the earlier ARISE study, which found a 2.9-day reduction in monthly migraine days, as well as Phase IIb data with erenumab in chronic migraine. Clinicians have suggested that for people whose lives are blighted by regular migraines then a one- or two-day reduction in migraine headache days per week is clinically significant.
The new results would seem to put erenumab on course for approval, although analysts are pretty divided over the prospects for the erenumab and the other CGRP inhibitors. Some predict that despite a clear medical need and large patient population, payer pushback will limit access and put considerable downward pressure on pricing.
Credit Suisse has suggested sales of erenumab could reach as high as $2.3 billion at peak, although Barclays Capital is much less optimistic, predicting a market share of 20%-25% and peak sales of $800 million.
"Our conservative position stems from the fact that headline numbers suggest that the secondary endpoint of a 50% reduction from baseline migraine days could be a factor that makes it difficult for erenumab to distinguish itself from the rest of the field," they said in a note issued today.
Amgen has commercialization rights to erenumab in the U.S., Canada and Japan, while Novartis will sell the drug in Europe and the rest of the world.
"This is a potentially life-changing medicine for migraine sufferers, and we're pleased to be in the lead position in the CGRP class," said Amgen CEO Robert Bradway.
"We believe the results of our [Phase IIb study] combined with our two Phase III studies in episodic migraine could support registration for both chronic and episodic migraine indications," he added.