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EU Accelerated Assessment Tracker: First Filing From Bluebird And Daiichi Keeping Mum

 
• By Maureen Kenny

As the European Medicines Agency gets on with its fast-track review of bluebird bio's LentiGlobin gene therapy, the Pink Sheet takes a look at the year so far in the area of accelerated assessment. Daiichi Sankyo is keeping us guessing on whether its investigational new product, quizartinib, will also be fast-tracked once filed.

Arrows
Getting ahead of the game matters to companies • Source: Shutterstock

Bluebird bio’s filing of a marketing authorization application (MAA) with the European Medicines Agency for its LentiGlobin gene therapy for the treatment of patients with transfusion-dependent β-thalassemia (TDT) brings to five the number of products being reviewed under the agency’s accelerated assessment mechanism.

The US company announced on Oct. 5 that the EMA had accepted its MAA for LentiGlobin in this indication under the fast-track mechanism, which can reduce the active review time for an MAA from 210 days to 150 days

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