EU Accelerated Assessment Tracker

Calliditas "Very Excited" By Success; Speedy Review Begins Of Takeda's Dengue Vaccine Candidate

28 Apr 2021

• By Maureen Kenny

Calliditas Therapeutics' lead product candidate Nefecon will be fast-tracked at the EMA once the marketing application is filed. Takeda and Bayer are hoping for the same success with maribavir and copanlisib respectively.

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 procedure.

The latest update – see table below – reflects developments from April 2021.