Dova Pharmaceuticals (NASDAQ:DOVA) announced on Monday that the US Food and Drug Administration has accepted for review its supplemental new drug application seeking approval for its drug Doptelet to treat another group of patients who suffer from low blood platelet counts.
This version of the new drug application is aimed at using Doptelet to address chronic immune thrombocytopenia (ITP) in patients who have had an insufficient response to a previous treatment.
ITP is an autoimmune bleeding disorder characterized by thrombocytopenia, an abnormally low level of platelets.
The goal date for an FDA decision on this supplemental new drug application is June 30 of next year.
Doptelet was approved by the FDA last May for the treatment of low blood platelet counts in patients with chronic liver disease who are set to undergo procedures.
“Acceptance of this supplemental new drug application is another significant milestone for Dova, and an important step towards addressing this underserved patient population and expanding the applications for Doptelet as a treatment for thrombocytopenia,” said Lee Allen, Dova’s chief medical officer in a statement. “We look forward to working closely with the FDA as they review this supplemental new drug application.”
Dova shares shed 2.8% on Monday to finish the day at $18.41 before bouncing to $18.55 in extended trading.