CHMP recommends Doptelet to treat severe thrombocytopenia in adult patients with chronic liver disease

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Doptelet, from Dova Pharmaceuticals, intended for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure. Doptelet will be available as 20 mg film-coated tablets.

The active substance of Doptelet is avatrombopag, a thrombopoietin receptor agonist (ATC code: B02BX) that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, resulting in increased production of platelets. The benefits with Doptelet are its ability to reduce the need for platelet transfusions before a scheduled invasive procedure or for rescue therapy for bleeding during the 7 days after the procedure. The most common side effect is fatigue.

The full indication is: “Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure”.