Dova Pharmaceuticals Announces Four Presentations on Avatrombopag in Patients with Chronic Immune Thrombocytopenia at the Int...
24 Juin 2019 - 2:00PM
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
- Authors: Liebman, H; Bussel JB
- Date/Time: Sunday, 07 July 2019, 18:30-19:30
Abstract PB0416: Comparable
Avatrombopag (AVA) Efficacy in Patients with Chronic Immune
Thrombocytopenia (c-ITP) Who had Received Prior Thrombopoietin
Receptor Agonist (TPO-RA) Treatment
- Authors: McCrae KR, Allen LF., Aggarwal K, Vredenburg M, Tian
W, Kuter D JB
- Date/Time: Sunday, 07 July 2019, 6:30-7:30
Abstract PB0399: Baseline
Endogenous Thrombopoietin Concentrations and Response to
Avatrombopag in Immune Thrombocytopenia
- Authors: Al-Samkari, Tian W, Kuter D JB
- Date/Time: Sunday, 07 July 2019, 18:30-19:30
Abstract PB0417:
Avatrombopag (AVA) Dosing Regimen in Chronic Immune
Thrombocytopenia (ITP)- A Dose Modeling Study
- Authors: Laliberte K; Peng J; Bush M; Aggarwal K; Vredenburg M;
Allen LF
- Date/Time: Sunday, 07 July 2019, 18:30-19:30
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
INDICATIONS
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.
CONTRAINDICATIONS:
None
ADVERSE REACTIONS
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.
Media Relations Contact
LDR CommunicationsLori Rosen(917)
553-6808Lori@ldrcommunications.com
Investor Relations Contact
Westwicke PartnersJohn Woolford(443)
213-0506john.woolford@westwicke.com
Dova Pharmaceuticals (NASDAQ:DOVA)
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