New EU Filings
Adagrasib, Mirati Therapeutics' treatment for patients with non-small cell lung cancer, is among the latest new medicines that have been submitted for review for potential pan-EU approval.
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Polyhexanide, from SIFI, could become the first approved treatment for acanthamoeba keratitis, while aflibercept could become the first biosimilar version of Eylea in the EU.
The sponsors of two monoclonal antibody products, tislelizumab and tremelimumab, are each seeking marketing approval for more than one indication.
Servier is trying again with Tibsovo in the EU, while Protalix is using June 2021 data to support its filing for pegunigalsidase, which the US regulator turned down last April.