Teva Pushes CGRP Timeline Back To End Of 2018
Management said the migraine drug fremanezumab could launch in the US by the end of the year following discussions with the US FDA. The June timeline has been delayed by a Celltrion manufacturing issue.
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Competition is hotting up in the CGRP class of new migraine therapies, with Lilly's Emgality being recommended for approval in Europe, paving the way for a market share battle with Novartis' Aimovig.
The US FDA approved Teva's fremanezumab dosed monthly and quarterly versus Amgen's monthly Aimovig, and will launch at the same price. However, it's packaged as a pre-filled syringe instead of an autoinjector, has a higher rate of injection site reactions and it may launch alongside Lilly's Emgality.
Teva has been able to hold onto a roughly 85% share of the Copaxone 40 mg market, but expects pressure from generics will intensify in the second half of the year.