China National Medical Products Administration Approves DOPTELET® (avatrombopag) for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure
-First Approval for DOPTELET in China and First-Ever Treatment for this Indication in China-
DURHAM, N.C., April 30, 2020 /PRNewswire/ -- AkaRx, Inc., a wholly owned subsidiary of Dova Pharmaceuticals, Inc, a Swedish Orphan Biovitrum AB (publ) (Sobi™) company, today announced DOPTELET® (avatrombopag) has been granted approval from the China National Medical Products Administration (NMPA) for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure (i.e., the CLD indication).
"We are pleased DOPTELET is now approved in China for the treatment of thrombocytopenia in patients with CLD ahead of a planned procedure, a routine consequence of the disease," said Mahmood Ladha, President and Head of Dova. "Receiving the approval for DOPTELET from the China NMPA marks another significant milestone for Dova and our growing leadership in the global treatment of thrombocytopenia. DOPTELET is the first treatment for this indication approved in China, offering patients a safe and effective orally-administered alternative to platelet transfusions for increasing platelet counts to the target level."
The approval was based on safety and efficacy data from two global Phase 3, double-blind, placebo-controlled trials, conducted in adults with severe thrombocytopenia (platelet count of less than 50,000/µL) and CLD. Both studies showed DOPTELET to be superior to placebo, in both the 40 mg and 60 mg treatment groups, in increasing the proportion of patients not requiring platelet transfusions or rescue procedures for bleeding up to 7 days following a scheduled procedure. DOPTELET was also shown to be superior to placebo in both secondary efficacy endpoints in each trial, i.e., the proportion of patients achieving a platelet count equal to or greater than 50,000/µL and the magnitude of the change in platelet counts from baseline to procedure day.
DOPTELET has received marketing approval for the CLD indication from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. DOPTELET is also approved by the FDA for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Jiangsu Wanbang Pharmaceutical Marketing and Distribution Co., Ltd., a subsidiary of Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd, has exclusive rights to distribute DOPTELET in China under a marketing and distribution agreement with AkaRx, Inc.
About Doptelet® (avatrombopag)
Doptelet® is an oral thrombopoietin (TPO) receptor agonist administered with food. Doptelet is approved by both the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for treatment of thrombocytopenia (low platelet counts) in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. In June 2019, Doptelet was approved by FDA for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. A phase 3 study of avatrombopag for chemotherapy-induced thrombocytopenia (CIT) is currently ongoing.
Indication and Important Safety Information (as approved in China)
DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
SELECTED IMPORTANT SAFETY INFORMATION
Warnings and Precautions
DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists. In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment- emergent event of portal vein thrombosis in a patient (n=1/430) with chronic liver disease and thrombocytopenia treated with DOPTELET. Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).
DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.
The most common adverse reactions (≥3%) were: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.
To report suspected adverse reactions, contact Dova Pharmaceuticals at 1-844-506-DOVA (3682) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full prescribing information for DOPTELET is available at www.Dova.com
About Dova Pharmaceuticals Dova Pharmaceuticals is a wholly owned subsidiary of Swedish Orphan Biovitrum AB (Publ) (Sobi) focused on commercializing Doptelet® (avatrombopag) for the treatment of thrombocytopenia. Doptelet is an oral thrombopoietin (TPO) receptor agonist administered with food. More information is available at www.dova.com. For more information about Sobi, visit www.sobi.com.
Media Contact: Viken Tachdjian Director, Patient Marketing & Communications 919-338-7929