Their drug Aimovig (erenumab) scored well in a study that recruited some of the toughest patients in the world of migraine sufferers; men and women whose persistent migraines have resisted multiple lines of therapy.
According to investigators, 30.3% of patients who had notched up two to four previous preventive treatment failures demonstrated at least a 50% drop in migraine days after being treated with Aimovig. They were randomized to receive monthly subcutaneous injections of either Aimovig 140 mg or placebo for 12 weeks.
The placebo arm of the study — which recruited a total of 246 patients — did significantly worse, with 13.7% hitting the same goal post.
Amgen and Novartis don’t have the only CGRP migraine drug headed to a likely approval. The data on these drugs aren’t dramatically different. Safety looks good. And players ranging from Teva to Eli Lilly to little Alder (and later Allergan) are all angling for their own piece of the pie. But the two heavyweights do have the first drug under review at the FDA, with a PDUFA date falling on May 17.
Way out front, they are likely to be the first to start changing the standard of care in the field. That’s a big deal, and one they promise to make the most of.
Clarivate has listed this as one of the top 10 drugs facing a rollout in 2018, with 2022 sales pegged at $1.17 billion.
“These data support the overall efficacy and safety profile we have seen consistently during extensive clinical study of Aimovig, and speak to its potential to help fill treatment gaps in more difficult patient populations whose migraine has not been adequately managed with current therapies,” noted Sean Harper, the head of R&D at Amgen.
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