Half Of All EU Fast-Track Requests Fail; AZ’s Imfinzi Among Latest

The European Medicines Agency recently denied AstraZeneca’s pre-filing request for accelerated assessment of Imfinzi in Stage III NSCLC, an indication the company is hoping to make its own. It’ll be no consolation that the EMA this year seems to have rejected as many fast-track requests as it has granted.

Dartboard on wood wall (miss darts)
AstraZeneca is not alone in missing its target of getting speedy EU review • Source: Shutterstock

Companies hoping to fast-track their products in Europe have about a 50/50 chance of getting on the accelerated assessment program at the European Medicines Agency.

In the year to date, the EMA’s Committee for Medicinal Products for Human Use has assessed pre-filing accelerated access requests...

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