Two Hopefuls And A ‘No’: EMA Decisions On Accelerated Access
Regeneron and Shire should find out this week whether the European Medicines Agency will agree to fast-track its review of their products.
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There has been a sharp fall in the number of companies seeking accelerated assessment for their investigational products at the European Medicines Agency. One such company that has asked – Dova Pharmaceuticals – is staying silent on the outcome of its request.
Shire and Regeneron/Sanofi are among the companies that have recently submitted investigational new treatments for approval across the EU.
Will the European Medicines Agency decide this week that Dova Pharmaceuticals’ eventual marketing authorization application for avatrombopag should be fast-tracked? If it does, the potential new thrombocytopenia therapy would join just a handful of products that are being reviewed under the EMA’s accelerated assessment pathway.