DOPTELET Has Differentiated Profile as The Only Oral Thrombopoietin Receptor Agonist (TPO-RA) Approved for Treatment of ITP Without Food Type Restrictions
DURHAM, N.C., July 19, 2019 (GLOBE NEWSWIRE) -- Dova Pharmaceuticals, Inc. (DOVA), a pharmaceutical company focused on acquiring, developing and commercializing drug candidates for diseases where there is a high unmet need, today announced the commercial availability of DOPTELET (avatrombopag) for treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. In June 2019, the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the use of DOPTELET to include this indication.
“As a growing leader in the treatment of thrombocytopenia, we are proud to make DOPTELET commercially available to healthcare providers and their adult patients with ITP,” said Jason Hoitt, chief commercial officer of Dova. “DOPTELET can easily integrate into a patient’s lifestyle, and it is the only oral thrombopoietin receptor agonist (TPO-RA) approved for treatment of thrombocytopenia in ITP patients without food type restrictions. With this differentiated profile, we believe DOPTELET is well-positioned to fill an unmet need in the ITP market.”
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. The European Commission has also granted marketing authorization for DOPTELET for the treatment of severe thrombocytopenia in adult patients with CLD who are scheduled to undergo an invasive procedure.
Dova is committed to enabling patient access to DOPTELET. DOPTELET is priced similarly to other TPO-RAs used to treat ITP, and Dova will continue to offer patient assistance and co-pay assistance programs to eligible patients.
Full prescribing information for DOPTELET is available on Dova’s website, www.Dova.com.
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
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.
Dose adjustments are recommended for patients with chronic immune thrombocytopenia taking moderate or strong dual CYP2C9 and CYP3A4 inducers or inhibitors.
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. 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.
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