EU Accelerated Assessment Tracker
Fast-Track Success For Origin Biosciences’ Rare Disease Drug Fosdenopterin
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.
You may also be interested in...
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 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.
Accelerated Assessment Success In EU For CSL Behring And Roche
There have been some recent successes on the accelerated assessment front in the EU but more requests are rejected than granted.