Dova Pharma's thrombocytopenia drug gets FDA approval

Reuters Health Information: Dova Pharma's thrombocytopenia drug gets FDA approval

Dova Pharma's thrombocytopenia drug gets FDA approval

Last Updated: 2018-05-21

By Reuters Staff

(Reuters) - The U.S Food and Drug Administration said on Monday it had approved Dova Pharmaceuticals Inc's oral drug to treat thrombocytopenia in chronic liver disease (CLD) patients who are scheduled to undergo a medical or dental procedure.

The drug, avatrombopag (Doptelet), belongs to a class of treatments called thrombopoietin receptor agonists (TPO RA), which stimulate platelet production, and is the first such treatment to be approved by the FDA for CLD patients.

A platelet transfusion is commonly recommended for thrombocytopenia patients undergoing procedures with risk of bleeding.

"This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions," said Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

According to a statement from Dova, "Two global Phase 3, double-blind, placebo-controlled trials . . . in adults with thrombocytopenia (platelet count of less than 50,000/ L) and CLD, supported FDA approval."

Japan-based Shionogi & Co Ltd is developing a similar drug and an FDA decision is due by late August.

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