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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EU Accelerated Assessment Tracker
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.
Janssen And Sanofi Keep Mum On EU Fast-Track Request Outcomes
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.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add a new product – Tibsovo, Servier’s treatment for IDH1-mutated acute myeloid leukemia and IDH1-mutated cholangiocarcinoma.