EU Accelerated Assessment Tracker: Rejection Is Standard Outcome For Fast-Track Requests This Year

 
• By Maureen Kenny and Neena Brizmohun

Attempts by companies to have their investigational products fast-tracked through the EU approval system this year so far have largely failed. Often the same products have or had priority review in the US. With the European Medicines Agency deciding on four new accelerated assessment requests this week, will the tide start to turn?

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Fast-Track Status Can Give Companies The Edge Over Competitors

Just one of the seven requests for accelerated assessment that the European Medicines Agency has processed this year is known to have been successful. One request has been granted, four have been denied and the outcomes of two are unknown.

Decisions are due to be taken on a further four requests this week. Also see " New EU Speedy Review Hopefuls: Novimmune, AveXis, bluebird bio, and Loxo Oncology " - Pink Sheet, 24 July, 2018. Three of the four latest requests are for products that are in the EMA's PRIME priority medicines scheme

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