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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?

 
• By Maureen Kenny

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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Shorter review timelines are available for innovative new therapies • Source: Shutterstock: Africa Studio

Janssen-Cilag and Sanofi have seemingly yet to disclose whether the investigational monoclonal antibodies they are developing – teclistamab and nirsevimab, respectively – will be fast-tracked at the European Medicines Agency when the companies file for approval.

Teclistamab is in development for the treatment of heavily pre-treated adult patients with relapsed or refractory multiple myeloma. Nirsevimab is being investigated as a first-in-class single dose immunization for the...

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