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EU Accelerated Assessment Tracker

Fast-Track Success For Janssen-Cilag’s Teclistamab

 
• By Maureen Kenny

Janssen-Cilag's EU filing for teclistamab is being reviewed under the European Medicines Agency’s accelerated assessment procedure. The outcome of Sanofi’s request relating to nirsevimab is not yet in the public domain.

This tracker provides information on accelerated assessment requests for planned marketing authorization applications (MAAs) that have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a decision. It also tracks whether companies retain fast-track status for MAAs as they make their way through the EU centralized drug evaluation procedure.

This latest update (see table at the end of this article) reflects recent developments. Specifically, it records the fact that teclistamab, an investigational monoclonal antibody under development at Johnson & Johnson subsidiary Janssen-Cilag International, has been granted accelerated assessment

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