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Janssen And Sanofi Keep Mum On EU Fast-Track Request Outcomes

Have Teclistamab And Nirsevimab Made The Grade For Speedy Review At The EMA?

Executive Summary

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. 

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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.

New EU Filings

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