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New EU Filings Include Tibsovo Resubmission, Pegunigalsidase & Daprodustat

 
• By Neena Brizmohun

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.

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New drugs have been submitted for review for potential EU marketing approval • Source: Almay

Servier has resubmitted a marketing application to the European Medicines Agency for its cancer drug, Tibsovo (ivosidenib tablets), more than a year after a previous EU filing was withdrawn for the product, which is approved in the US for treating acute myeloid leukemia (AML) and cholangiocarcinoma.

In addition, the EMA has started reviewing a marketing authorization application (MAA) for pegunigalsidase alfa, the potential treatment for Fabry disease from Protalix BioTherapeutics/

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