Double Approval Boost For Dova’s Doptelet But EU Licensee Still Sought

Two new approvals have given a fillip to Dova Pharmaceuticals Inc.’s oral thrombopoietin receptor agonist Doptelet (avatrombopag). The European Medicines Agency has approved it for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure, a decision that came just two days before the US Food and Drug Administration expanded the product’s US label to include the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

The market for ITP is bigger and more established that that for CLD patients, Dova noted, and the new label should provide the product with a clear path to commercial...