FDA approved Doptelet avatrombopag from the AkaRx Inc. subsidiary of Dova Pharmaceuticals Inc. (NASDAQ:DOVA) to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. The agency said it is the first drug approved in the indication.
Dova plans to launch Doptelet next month, at which time it will disclose pricing details.
Last year, Dova said Doptelet met the primary endpoints in two placebo-controlled Phase III trials, ADAPT-1 and ADAPT-2. The endpoints evaluated the proportion of patients who did not require a platelet transfusion or any rescue procedure for bleeding up to seven days following their elective procedure.
An MAA for Doptelet in the indication is under EMA review. Next half, Dova expects to submit an sNDA to FDA for the therapy to treat chronic immune thrombocytopenia purpura (ITP). Doptelet is an oral thrombopoietin (TPO) receptor (CD110; Mpl) agonist.
Doptelet is in Phase III testing for patients with thrombocytopenia regardless of disease etiology undergoing surgery or pre-surgery. This quarter, Dova plans to start a Phase III trial evaluating Doptelet in patients who have developed chemotherapy-induced thrombocytopenia.
Dova gained exclusive, worldwide rights to Doptelet through its 2016 acquisition of AkaRx from Eisai Co. Ltd. (Tokyo:4523). AkaRx had the drug's rights from Astellas Pharma Inc. (Tokyo:4503).
An CD110 agonist from Shionogi & Co. Ltd. (Tokyo:4507), lusutrombopag, is under FDA Priority Review to treat thrombocytopenia associated with chronic liver disease in patients undergoing elective invasive procedures. The PDUFA date is Aug. 26.
Lusutrombopag is approved in Japan as Mulpleta in the indication. An MAA for the therapy is under EMA review.
Dova fell $3.67 (13%) to $24.17 on Monday.