Amgen Plans 2017 Filings After Second Phase III CGRP Inhibitor Success
A second Phase III success for erenumab keeps Amgen on track to seek regulatory approvals in 2017, which means the company could win the first US FDA approval for a CGRP inhibitor to treat migraine headaches.
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Keeping Track: A Diverse Array Of Approvals, A CRL For Evolus' Botox Competitor, And Coherus Refiles Neulasta Biosimilar
The latest drug development news and highlights from our US FDA Performance Tracker.
Amgen and Novartis won the first US FDA approval for a CGRP inhibitor in the prevention of migraine headaches. The companies aim to quickly capture a big share of what they estimate to be an 8m-patient market in the US with a $6,900 per year price tag.
Amgen ended its own development of the CETP inhibitor AMG 899, but will see if anyone else wants to license the drug. Meanwhile, the company is focusing on new drugs and assets in development to offset declining sales for Enbrel and other blockbusters.