Regulatory Affairs

FDA approves Dova’s Doptelet for thrombocytopenia in adults with CLD

PBR Staff Writer Published 22 May 2018

Dova Pharmaceuticals’ subsidiary AkaRx has secured approval from the US Food and Drug Administration (FDA) for its Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in patients with chronic liver disease (CLD).

The approval for the thrombopoietin (TPO) receptor agonist is for adult patients who are scheduled to go through a medical or dental procedure. The regulator said Doptelet is the first drug to be indicated for this use.

FDA center for drug evaluation and research office of hematology and oncology products acting director Richard Pazdur said: “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.”

The FDA approval was based on the results shown by Doptelet in two phase 3 trials ADAPT-1 and ADAPT-2 in 435 patients with chronic liver disease and severe thrombocytopenia. All the enrolled patients were to go through a procedure that would typically need platelet transfusion.

Compared to placebo, which was no treatment, Doptelet administered orally over five days in two dose levels helped in boosting platelet counts in a higher percentage of patients.

Further, patients who received Doptelet were not required to undergo platelet transfusion or any rescue therapy on the day of the procedure and up to seven days after the procedure, compared to those in the placebo arm.

Dova Pharmaceuticals president and CEO Alex Sapir said: “Doptelet  is the first orally administered treatment option for patients with CLD, allowing the majority of patients to avoid a platelet transfusion prior to a procedure by increasing platelet counts to the target level of greater or equal to 50,000 per microliter.

“Given our extensive preparations to date, we are positioned to launch Doptelet June with our full complement of sales, marketing, and reimbursement support resources.”

The North Carolina-based Dova Pharmaceuticals became the owner of Doptelet following the acquisition of Eisai in March 2016 which had acquired AkaRx in 2010 for $255m.

Image: FDA Building 51 in Silver Spring, Maryland which houses the Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration/