Dova Pharmaceuticals Announces European Union Marketing Authorization for DOPTELET® (avatrombopag) for the Treatment of Thro...
25 Giugno 2019 - 2:00PM
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.
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 US Prescribing Information for
DOPTELET (avatrombopag) www.doptelet.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 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.
Cautionary Notes Regarding
Forward-Looking Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995. These statements may be identified by words such
as “anticipated”, “believe”, “expect”, “may”, “plan”, “potential”,
“will”, and similar expressions, and are based on Dova’s current
beliefs and expectations. These forward-looking statements
include expectations regarding the commercial launch of DOPTELET
within the European Union for the treatment of severe
thrombocytopenia in adult patients with CLD who are scheduled to
undergo an invasive procedure, and Dova’s ability to develop
commercialization capabilities with a partner within the European
Union. These statements involve risks and uncertainties that
could cause actual results to differ materially from those
reflected in such statements. Risks and uncertainties that
may cause actual results to differ materially include uncertainties
inherent in the conduct of clinical trials, increased regulatory
requirements, Dova’s reliance on third parties over which it may
not always have full control, and other risks and uncertainties
that are described in Dova’s Annual Report on Form 10-K for the
year ended December 31, 2018, filed with the U.S. Securities and
Exchange Commission (SEC) on March 5, 2019, Dova’s Quarterly Report
on Form 10-Q for the quarter ended March 31, 2019, filed with the
SEC on May 7, 2019, and Dova’s other periodic reports filed with
the SEC. Any forward-looking statements speak only as of the
date of this press release and are based on information available
to Dova as of the date of this release, and Dova assumes no
obligation to, and does not intend to, update any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Media Relations Contact LDR Communications Lori
Rosen (917) 553-6808 Lori@ldrcommunications.com
Investor Relations Contact Westwicke Partners
John Woolford (443) 213-0506 john.woolford@westwicke.com
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