1. Pink Sheet

EU Accelerated Assessment Tracker

 
• By Maureen Kenny

Sanofi appears to have failed to convince the European Medicines Agency that its just-filed marketing authorization application for isatuximab should be granted accelerated assessment. AB Science's request regarding its planned MAA for masitinib has been rejected and Alnylam is declining to disclose the fate of its request relating to givosiran. See our latest updates in the tracker below.

The tracker below provides information on accelerated assessment requests for planned marketing authorization applications (MAAs) that are known to have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a decision since January 2018.

There are updates relating to March, April and May 2019. The application from Sanofi for isatuximab appears to have been rejected. The request from AB Science relating to...

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