-Approval Based on Positive Efficacy and Safety Data from Two Phase 3 Clinical Trials-
-Company Intends to Partner for the European Commercialization of DOPTELET-
DURHAM, NC, USA I June 25, 2019 I Dova Pharmaceuticals, Inc. (NASDAQ: DOVA), a pharmaceutical company focused on acquiring, developing and commercializing drug candidates for diseases where there is a high unmet need, today announced that the European Commission (EC) has granted marketing authorization for DOPTELET® (avatrombopag) for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure.
“Receiving the European marketing authorization for DOPTELET marks another significant milestone for Dova and our growing leadership in the treatment of thrombocytopenia,” said Dr. David Zaccardelli, president and chief executive officer of Dova. “As an oral thrombopoietin receptor agonist that can raise platelet levels in CLD patients with thrombocytopenia ahead of an invasive procedure, DOPTELET offers a safe and effective alternative to platelet transfusions. Conversations with potential commercial partners are ongoing to make DOPTELET available in Europe.”
Safety and efficacy data from two global Phase 3, double-blind, placebo-controlled trials, conducted in adults with thrombocytopenia (platelet count of less than 50,000/µL) and CLD, supported the EC marketing authorization. DOPTELET was shown to be superior to placebo in increasing the proportion of patients not requiring platelet transfusions or rescue procedures for bleeding up to 7 days following a scheduled procedure in both trials and both the 40 mg and 60 mg treatment groups. DOPTELET was also superior to placebo at the two 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.
The marketing authorization applies to all 28 European Union member states plus Iceland, Norway, and Liechtenstein.
For DOPTELET EU product information, please see this link.
DOPTELET was approved by the U.S. Food and Drug Administration for the treatment of thrombocytopenia in adult patients with CLD who are scheduled to undergo a procedure in May 2018.
Indications and Important Safety Information
(Based on FDA-Approved Labeling)
INDICATIONS
DOPTELET (avatrombopag) is approved for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
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 and the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. For more information, visit www.Dova.com.
SOURCE: Dova Pharmaceuticals
Post Views: 64
-Approval Based on Positive Efficacy and Safety Data from Two Phase 3 Clinical Trials-
-Company Intends to Partner for the European Commercialization of DOPTELET-
DURHAM, NC, USA I June 25, 2019 I Dova Pharmaceuticals, Inc. (NASDAQ: DOVA), a pharmaceutical company focused on acquiring, developing and commercializing drug candidates for diseases where there is a high unmet need, today announced that the European Commission (EC) has granted marketing authorization for DOPTELET® (avatrombopag) for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure.
“Receiving the European marketing authorization for DOPTELET marks another significant milestone for Dova and our growing leadership in the treatment of thrombocytopenia,” said Dr. David Zaccardelli, president and chief executive officer of Dova. “As an oral thrombopoietin receptor agonist that can raise platelet levels in CLD patients with thrombocytopenia ahead of an invasive procedure, DOPTELET offers a safe and effective alternative to platelet transfusions. Conversations with potential commercial partners are ongoing to make DOPTELET available in Europe.”
Safety and efficacy data from two global Phase 3, double-blind, placebo-controlled trials, conducted in adults with thrombocytopenia (platelet count of less than 50,000/µL) and CLD, supported the EC marketing authorization. DOPTELET was shown to be superior to placebo in increasing the proportion of patients not requiring platelet transfusions or rescue procedures for bleeding up to 7 days following a scheduled procedure in both trials and both the 40 mg and 60 mg treatment groups. DOPTELET was also superior to placebo at the two 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.
The marketing authorization applies to all 28 European Union member states plus Iceland, Norway, and Liechtenstein.
For DOPTELET EU product information, please see this link.
DOPTELET was approved by the U.S. Food and Drug Administration for the treatment of thrombocytopenia in adult patients with CLD who are scheduled to undergo a procedure in May 2018.
Indications and Important Safety Information
(Based on FDA-Approved Labeling)
INDICATIONS
DOPTELET (avatrombopag) is approved for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
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 and the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. For more information, visit www.Dova.com.
SOURCE: Dova Pharmaceuticals
Post Views: 64
