New EU Filings
Infigratinib, Helsinn Group’s treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements, is among the latest new medicines that have been submitted for review for potential pan-EU approval.
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The filing for Origin Biosciences’ fosdenopterin (Nulibry) is being fast-tracked at the European Medicines Agency. The outcomes of accelerated assessment requests from Janssen and Sanofi for teclistamab and nirsevimab respectively appear not yet to be in the public domain.
Teclistamab and nirsevimab may or not be fast-tracked when their sponsors – Janssen-Cilag and Sanofi, respectively – file for pan-EU approval. In the meantime, a total of seven filings are currently benefiting from the accelerated assessment mechanism at the European Medicines Agency.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.