(Reuters) - The U.S Food and Drug Administration said on Monday it had approved Dova Pharmaceuticals Inc’s drug to treat low blood platelet count in chronic liver disease (CLD) patients, who are scheduled to undergo a medical procedure.
The drug to treat thrombocytopenia 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.
Thrombocytopenia is a common complication seen in chronic liver disease patients caused by a low blood platelet count, which may result in severe bleeding.
A blood platelet transplant is commonly recommended for thrombocytopenia patients undergoing medical procedures such as liver biopsy.
“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.
Japan-based Shionogi & Co Ltd is developing a similar drug and an FDA decision is due by late August.
Shares of Dova were halted on the Nasdaq.
Reporting by Manas Mishra and Sharnya G in Bengaluru; Editing by Sai Sachin Ravikumar and Anil D'Silva