Speed Is Everything In CGRP Race As Amgen/Novartis Reveal Phase III Data
Amgen and Novartis revealed the first set of Phase III data for a CGRP inhibitor in the treatment of episodic migraine, potentially positioning the companies’ biologic erenumab at the head of the drug class.
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Amgen will be the first biopharma company to seek approval for a CGRP inhibitor when it submits a BLA for FDA approval later in the second quarter, but Alder, Lilly, Teva and Allergan are in the running for best-in-class status to treat unmet needs in migraine and other headache markets.
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.