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 the U.S. Food and Drug Administration (FDA) approved a
supplemental New Drug Application (sNDA) that expands the use of
DOPTELET (avatrombopag) to include the treatment of
thrombocytopenia in adults with chronic immune thrombocytopenia
(ITP) who have had an insufficient response to a previous
treatment.
DOPTELET is also FDA-approved for the treatment of
thrombocytopenia in adult patients with chronic liver disease (CLD)
who are scheduled to undergo a procedure. Earlier this week,
Dova announced the marketing authorization granted by the European
Commission for DOPTELET for the treatment of severe
thrombocytopenia in adult patients with CLD who are scheduled to
undergo an invasive procedure.
“Dova is pleased to provide DOPTELET to patients and physicians
in the United States for the treatment of chronic ITP in adult
patients who have had an insufficient response to a previous
treatment,” said Dr. David Zaccardelli, president and CEO of Dova.
“In addition to offering patients with ITP a new treatment option,
we expect DOPTELET will also address an important unmet medical
need in the market. We sincerely thank the patients and
dedicated researchers who participated in our clinical program as
well as FDA for their collaboration during the review of this
application.”
DOPTELET is an oral, thrombopoietin receptor agonist (TPO-RA)
administered with food. In the pivotal Phase 3 study,
DOPTELET administration resulted in a platelet count of at least
50,000 per µL at day eight of therapy in the majority of patients,
with efficacy superior to placebo in maintaining platelet counts in
the target range during the 6-month treatment period.
Additional supportive efficacy data for the ITP sNDA were provided
by two Phase 2 ITP clinical trials, as well as two Phase 3
trials for the treatment of thrombocytopenia in patients with
CLD.
Safety data for 128 patients with ITP, and more than 1,000
subjects treated across 24 studies in the DOPTELET clinical
development program across multiple indications, support the safety
and tolerability of DOPTELET.
“ITP patients should work with their clinician to choose a
therapy that supports their lifestyle and aims to achieve the best
possible result to treat their ITP. That’s why having additional
treatment options are so important,” said Caroline Kruse, president
and CEO of the Platelet Disorder Support Association, a patient
advocacy organization dedicated to ITP patients. “We are thrilled
to have a new, oral TPO-RA available for adult patients with
ITP. Every new treatment provides more choices and new hope
to our community.”
Dova is committed to enabling patient access to DOPTELET.
DOPTELET will be priced similarly to other TPO-RAs used to treat
ITP, and Dova will continue to offer Patient Assistance and Co-Pay
programs. The commercial launch of DOPTELET for ITP is anticipated
to occur in mid-July 2019.
Dova also entered into an expanded partnership in the United
States with Salix. Starting on July 1, 2019, in addition to the
gastroenterology, colorectal surgery, and proctology segments,
Salix will have the exclusive right to co-promote the CLD
indication for DOPTELET to the hepatology and interventional
radiology segments. Dova will continue to pay Salix a
commission based on a percentage of net sales in these specialties,
which will be in the mid-thirties beginning on July 1, 2019.
In addition, the co-promotion agreement was extended to September
2023.
Dr. Zaccardelli added, “The expanded partnership with Salix
builds additional momentum for DOPTELET and enables the Dova team
to focus on a successful launch of the ITP indication. As a growing
leader in the treatment of thrombocytopenia, we are committed to
realizing DOPTELET’s significant market opportunity in CLD, ITP and
potentially chemotherapy-induced thrombocytopenia (CIT) for which
we expect Phase 3 trial top-line results in the first half of
2020.”
Full prescribing information for DOPTELET is available on Dova’s
website, www.Dova.com.
Company to Host Conference Call
Dova will host a conference call today, June 27, 2019 at 9:00
a.m. ET to discuss the approval. A question-and-answer session will
follow Dova's remarks.
To participate on the live call, please dial 866-550-8145
(domestic) or +1-430-775-1344 (international) and provide the
conference ID 2498719 five to 10 minutes before the start of the
call.
A live audio webcast of the call will also be available via the
"Investor Relations" page of the Dova website, www.dova.com. Please
log on through Dova's website approximately 10 minutes before the
scheduled start time. A replay of the webcast will be archived on
Dova's website for 90 days following the call.
About Immune Thrombocytopenia (ITP) ITP is a
rare, autoimmune bleeding disorder that affects approximately
60,000 adults in the United States. It is characterized by
low numbers of platelets that lead to excessive bruising and severe
bleeding. ITP is considered chronic when symptoms last more than 12
months. Fatigue and depression are often associated with ITP,
and the daily fear of severe bleeding can limit a patient’s work
life as well as social and leisure activities. Finding a
treatment that works without side effects or lifestyle disruptions
is another challenge for ITP patients. While there is no
cure, TPO-RAs are commonly used to manage the disease
effectively. However, factors such as weekly subcutaneous
administration, potential liver toxicities, and food restrictions
can be significant barriers to effective TPO-RA treatment.
Indication and Important Safety
Information
INDICATION
DOPTELET® (avatrombopag) is indicated for the
treatment of thrombocytopenia in adult patients with:
- Chronic liver disease who are scheduled to undergo a
procedure.
- Chronic immune thrombocytopenia who have had an insufficient
response to a previous treatment.
IMPORTANT SAFETY INFORMATION FOR DOPTELET
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
or chronic immune thrombocytopenia. Portal vein thrombosis has been
reported in patients with chronic liver disease, and thromboembolic
events (arterial and venous) have been reported in patients with
chronic immune thrombocytopenia treated with TPO receptor
agonists.
In clinical trials, 0.2% (1/430) of patients with
chronic liver disease treated with DOPTELET developed a
treatment-emergent event of portal vein thrombosis. In clinical
trials in patients with chronic immune thrombocytopenia, 7% (9/128)
of patients treated with DOPTELET developed a thromboembolic
event.
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 or chronic immune thrombocytopenia in an
attempt to normalize platelet counts. Follow the dosing guidelines
to achieve target platelet counts. Monitor patients receiving
DOPTELET for signs and symptoms of thromboembolic events and
institute treatment promptly.
Contraindications:
None
Drug Interactions
Dose adjustments are recommended for patients
with chronic immune thrombocytopenia taking moderate or strong dual
CYP2C9 and CYP3A4 inducers or inhibitors.
Adverse Reactions
The most common adverse reactions (≥3%) in
patients with chronic liver disease were: pyrexia, abdominal pain,
nausea, headache, fatigue, and peripheral edema.
The most common adverse reactions (≥10%) in
patients with chronic immune thrombocytopenia were: headache,
fatigue, contusion, epistaxis, upper respiratory tract infection,
arthralgia, gingival bleeding, petechiae, and nasopharyngitis.
Please see Full Prescribing Information for DOPTELET
(avatrombopag) at this link.
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 potential opportunities for
DOPTELET, which include Salix’s ability to continue
commercialization capabilities with CLD in the United States, the
pricing of DOPTELET, the timing of commercial launch of DOPTELET
for ITP, the timing of results from Dova’s Phase 3 clinical trial
for the treatment of chemotherapy-induced thrombocytopenia and the
potential to expand the treatment applications for DOPTELET to CIT
and other indications. 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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