Dova Pharmaceuticals Inc. (NASDAQ: DOVA) shares dropped on Monday following a critical update from the U.S. Food and Drug Administration (FDA) on one of its subsidiaries. Essentially, the agency granted a Priority Review for Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.
Note that this is the first drug approved by the FDA for this use.
For some quick background: thrombocytopenia is a condition in which there is a lower-than-normal number of circulating platelets in the blood. When patients have moderately to severely reduced platelet counts, serious or life-threatening bleeding can occur, especially during invasive procedures.
The safety and efficacy of Doptelet was studied in two trials. The results showed that for both dose levels of Doptelet, a higher proportion of patients had increased platelet counts and did not require platelet transfusion or any rescue therapy on the day of the procedure and up to seven days following the procedure as compared to those treated with placebo.
Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, commented:
Patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding. Doptelet was demonstrated to safely increase the platelet count. This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions.
Shares of Dova were last seen down about 7% at $25.87, with a consensus analyst price target of $41.40 and a 52-week trading range of $16.92 to $37.00.
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