Dova Aims For Accelerated Assessment In EU For Avatrombopag
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.
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Dova’s avatrombopag, which was recently approved in the US under priority review, has been refused an accelerated assessment in the EU.
Dova CEO Alex Sapir very confident of oral thrombopoietin receptor antagonist’s chances of taking market share from current standard of care, platelet transfusions, citing safety and convenience advantages.
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.