(avatrombopag) tablets, for oral use Initial U.S. Approval: 2018 . All rights reserved. The site is secure. FDA approved avatrombopag (Doptelet, AkaRx Inc.) for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure. Avatrombopag | C29H34Cl2N6O3S2 | CID 9852519 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities . Phase 3 randomization study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia [published online September 7, 2018]. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Epub 2019 Aug 5. Front Pharmacol. 2012 Sep;19(5):392-8 This is the first drug approved for this use by the FDA.1 Dublin, Oct. 14, 2022 (GLOBE NEWSWIRE) -- The "Thrombocytopenia - Market Insight, Epidemiology And Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.The Thrombocytopenia market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Thrombocytopenia market size. This phase 3 study, the first the evaluate avatrombopag in children, will evaluate efficacy, safety . Each DOPTELET tablet contains 20 mg avatrombopag (equivalent to 23.6 mg of avatrombopag maleate) and the following inactive ingredients: lactose monohydrate, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Before sharing sensitive information, make sure you're on a federal government site. Enrollment remains ongoing for the phase 3 clinical study for the treatment of patients with CIT. Liver cancer patients (including primary liver cancer and colorectal cancer liver . led avatrombopag to be approved by the FDA in 2018 for the treatment of thrombocytopenia in adults with CLD who are scheduled to undergo a medical or dental procedure (Food and Drug Administration, 2018). Avatrombopag, as a novel oral TPO receptor agonist, has been approved recently as an alternative treatment for PLT in the treatment of invasive surgery for CLD patients with severe TCP. Deng J, Hu H, Huang F, Huang C, Huang Q, Wang L, Wu A, Yang J, Qin D, Zou W, Wu J. Additional safety and tolerability findings were supported by the results of more than 1000 patients in studies of avatrombopag across multiple indications. The report also covers . The FDA approved a supplemental New Drug Application for avatrombopag as a treatment for adult patients with chronic immune thrombocytopenia who have had an insufficient response to a prior therapy. The safety data yielded in the trial proved consistent with phase II studies and 6-month studies that evaluated other thrombopoietin receptor agonists, with headaches being the most frequently reported AE. DGIdb, The Drug Gene Interaction Database, is a research resource that can be used to search candidate genes or drugs against the known and potentially druggable genome. Brand name: Doptelet Avatrombopag Effectively Maintained Platelet Counts in a Patient with Immune Thrombocytopenia Who Was Intolerant to Tyrosine Kinase Inhibitor Therapy. Avatrombopag was first approved as Doptelet on 2018-05-21. Tu X, Xue A, Wu S, Jin M, Zhao P, Zhang H. Front Pharmacol. -, Blood. HHS Vulnerability Disclosure, Help We sincerely thank the patients and dedicated researchers who participated in our clinical program as well as [the] FDA for their collaboration during the review of this application.. A detailed picture of the Doptelet (avatrombopag) in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United . Front Pharmacol. The .gov means its official.Federal government websites often end in .gov or .mil. stomach pain or tenderness. Published June 27, 2019. https://bit.ly/2Xy92dv. These patients were randomized to either receive avatrombopag (n = 32) or placebo (n = 17). Brief Summary: This is a multicenter, open-label, prospective one arm study to explore the efficacy and safety of Avatrombopag in non-severe aplastic anemia. The site is secure. Introduction: The thrombopoietin receptor agonists (TPO-RAs) are a class of drugs that have been FDA-approved for immune thrombocytopenia (ITP), periprocedural thrombocytopenia in patients with chronic liver disease (CLD), aplastic anemia, and thrombocytopenia associated with antiviral treatment of hepatitis C. Avatrombopag is a TPO-RA that is currently FDA-approved for ITP and periprocedural . Avatrombopag (Doptelet) is an orally bioavailable, small molecule thrombopoietin receptor agonist that has been developed by Dova Pharmaceuticals for the treatment of thrombocytopenic disorders. The https:// ensures that you are connecting to the Avatrombopag is also used to treat people with a certain blood disorder known as chronic immune thrombocytopenia-ITP. stop, or change the dosage of any medicines without your doctor's approval. Additional topics include: approved . If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. . Two grade 4 TEAEs were also reported in the core study; one patient experienced a cerebrovascular accident who discontinued study treatment and the other experienced worsening ITP, which was not deemed to be associated with the drug. The commercial launch for avatrombopag in this setting is anticipated to occur in mid-July 2019, the company stated. Doptelet (avatrombopag) - Drug Insight and Market Forecast report is published on August 6, 2020 and has 80 pages in it. The approval of the oral thrombopoietin receptor agonist is mostly based on findings from a phase III trial, which demonstrated that avatrombopag led to a platelet count of >50,000 per L after 8 days of therapy in the majority of patients with chronic ITP, and was also superior to placebo in maintaining platelet counts in the target range during a 6-month period. Results also showed that 5 of the 15 patients who were on concomitant ITP medication in the avatrombopag arm reduced their use of this medication from baseline, while none of the 8 patients who received placebo were able to do so (33.3% vs 0%, respectively; 95% CI, 9.48%-57.19%). Avatrombopag was deemed to be well tolerated with a safety profile comparable with placebo when adjusted for treatment exposure. Doptelet (avatrombopag) is a second generation, orally administered thrombopoietin receptor agonist (TPO-RA) indicated for the treatment of: It has been approved in Europe to treat thrombocytopenia. The decision to approve avatrombopag was also supported by 2 phase II clinical trials and 2 phase III studies in thrombocytopenia in patients with chronic liver disease (CLD). Avatrombopag was previously approved by the agency for treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. 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. DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with: Chronic liver disease who are scheduled to undergo a procedure. Alternate Names: E-5501 YM-477 AVATROMBOPAG E5501 chembl:CHEMBL2103883 . Data showed that avatrombopag was superior to placebo in the cumulative number of weeks of platelet response with a significantly longer duration of a platelet count 50 109/L in the absence of rescue therapy versus placebo (median, 12.4 vs 0.0 weeks; mean,12.0 vs 0.1 weeks;P<.0001). Basel, June 11, 2015 - Novartis announced today that the US Food and Drug Administration (FDA) has approved Promacta (eltrombopag) for the treatment of children six years and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. According to the manufacturer's instructions, a daily dose of 20-40 mg is recommended for patients with chronic ITP, and the . Jurczak W, Chonjnowski K, Mayer J, et al. 2016;2016:1802932 -, J Hepatol. May 21, 2018 The U.S. Food and Drug Administration today approved Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who. Generic name: avatrombopag Hepatologists and gastroenterologists should be aware of this new option for their patients with chronic liver disease and thrombocytopenia. Treatment for: Thrombocytopenia, Idiopathic Thrombocytopenic Purpura. government site. Due to its safety and effectiveness, avatrombopag was approved by the FDA to treat chronic ITP in adults (Provan et al., 2019) and thrombocytopenia in adult patients with chronic liver disease (Shirley, 2018). Careers. Four patients in the avatrombopag arm experienced grade 3 treatment-emergent adverse events (TEAEs), such as epistaxis, petechiae, headache, and platelet count reduction. Drugs Today (Barc). Disclaimer, National Library of Medicine Only 3/17 (17.6%) of patients in the placebo arm were exposed to study medication over 18 weeks, and only 1 patient was exposed for longer than 26 weeks. It is already approved in the United States and Europe as a therapy to increase. Christine M. Judge, MS and Atif Zaman, MD, MPH. Forty-eight healthy subjects received single 20 mg doses of avatrombopag alone or with one of 3 CYP2C9/3A . An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA approves new drug for patients with chronic liver disease who have low blood platelets and are undergoing a medical procedure, Office of Hematology and Oncology Products. Avatrombopag is a thrombopoietin receptor agonist (TPO-RA). Dova Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application for DOPTELET (avatrombopag) for Treatment of Chronic Immune Thrombocytopenia (ITP). This article summarizes the milestones in the development of avatrombopag leading to this first approval for the treatment of thrombocytopenia in adult patients with CLD. Patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding, said Richard Pazdur, M.D., director of the FDAs Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDAs Center for Drug Evaluation and Research. Regarding safety, patients in the avatrombopag arm experienced grade 3 treatment-emergent adverse events (TEAEs), including epistaxis, petechiae, headache, and platelet count reduction. Patients meeting the inclusion and exclusion criteria would be recruited. doi: 10.12659/AJCR.933788. Dova Pharmaceuticals Announces FDA Approval of Doptelet (avatrombopag) for Treatment of Chronic Immune Thrombocytopenia (ITP), FDA Approves Doptelet (avatrombopag) for Chronic Liver Disease Patients with Thrombocytopenia who are Undergoing a Medical Procedure, Dova Pharmaceuticals Announces FDA Acceptance of the Avatrombopag New Drug Application (NDA) with Priority Review, Dova Pharmaceuticals Announces New Drug Application Submission to FDA for Avatrombopag, a Second Generation Thrombopoietin Receptor Agonist. Epub 2021 Oct 28. The trials investigated two dose levels of Doptelet administered orally over five days as compared to placebo (no treatment). The FDA's Center for Drug Evaluation and Research (CDER) has approved a total of 219 new drugs in the calendar years 2015-2019. Was deemed to be well tolerated with a safety profile comparable with placebo when adjusted treatment! 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