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DURHAM, N.C., June 24, 2019 (GLOBE NEWSWIRE) -- Dova Pharmaceuticals, Inc. (NASDAQ: DOVA) today announced the Company will present four abstracts with data from studies of avatrombopag in patients with chronic immune thrombocytopenia (ITP) at the 65th International Society on Thrombosis and Haemostasis (ISTH) Annual Scientific Meeting, being held July 6-10, 2019, in Melbourne, Australia. These presentations will detail the safety and efficacy of avatrombopag from clinical trials in patients with ITP and the results of a dosing model study.
Details for the ISTH presentations are as follows:
Abstract PB0418: Lack of Clinically Significant Hepatotoxicity in Patients with Chronic Immune Thrombocytopenia (c-ITP) Treated with the Novel, Oral Thrombopoietin Receptor Agonist Avatrombopag- Pooled Safety Analysis of Four Clinical Trials
In addition, Dova has submitted a supplemental New Drug Application (sNDA) for DOPTELET (avatrombopag) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment, with a Prescription Drug User Fee Act (PDUFA) goal date of June 30, 2019. The NDA for DOPTELET for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure was approved on May 21, 2018.
Indications and Important Safety Information
DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
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.
Most common adverse reactions (≥ 3%) are: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.
Please see full Prescribing Information for DOPTELET (avatrombopag) www.dova.com
About Dova Pharmaceuticals, Inc.
Dova is a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for diseases where there is a high unmet need, with an initial focus on addressing thrombocytopenia. Dova’s proprietary pipeline includes one commercial product, DOPTELET, for the treatment of thrombocytopenia in adult patients with chronic liver disease scheduled to undergo a procedure.
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