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FDA Extends Use of Promacta (eltrombopag) in Pediatric Patients with Immune Thrombocytopenic Purpura

Posted 24 Aug 2015 by Drugs.com

August 24, 2015 – The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these children when they have not achieved an appropriate response using other ITP medicines or surgery to remove the spleen. ITP is a disorder that results in an abnormally low number of platelets, the cells that help your blood clot. Without enough platelets, bleeding can occur under the skin, in mucous membranes (such as in the mouth) or in other parts of the body. “Today’s approval of Promacta emphasizes the FDA’s commitment to fully developing treatments in areas of pediatric hematology and oncology,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Cen ... Read more

Related support groups: Idiopathic (Immune) Thrombocytopenic Purpura, Promacta, Eltrombopag

Promacta Approval Expanded to Kids With Rare Blood Disorder

Posted 24 Aug 2015 by Drugs.com

MONDAY, Aug. 24, 2015 – U.S. Food and Drug Administration approval of the drug Promacta (eltrombopag) has been expanded to include children one year and older with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). ITP is characterized by a low blood platelet count. Promacta is now approved for the disorder among children who have had unsatisfactory results with other drugs, or with surgery to remove the spleen, the agency said in a news release. Platelets help blood clot, and people with ITP can develop bleeding under the skin or in mucous membranes such as the mouth. Once-daily Promacta is designed to help increase platelet production, the FDA said. The drug, available in pill or powder form, was clinically evaluated in a trial involving 159 people. Some 62 percent of those who took Promacta saw an improvement in platelet count, compared with 32 percent among ... Read more

Related support groups: Idiopathic (Immune) Thrombocytopenic Purpura, Thrombotic Thrombocytopenic Purpura, Promacta, Eltrombopag, Thrombocytopenia Autoimmune

FDA Approves Promacta for New Pediatric Chronic Immune Thrombocytopenia (cITP) Indication

Posted 14 Jun 2015 by Drugs.com

SAN DIEGO, June 12, 2015 --(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that the FDA has approved a supplemental New Drug Application (sNDA) for the use of Promacta (eltrombopag), a Novartis product, for the treatment of children six years and older with chronic immune thrombocytopenia (cITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was approved by the FDA in 2008 for use in adult patients with the same condition4. Promacta was acquired by Novartis in March 2015 from GSK. Promacta was discovered as a result of research collaboration between GSK and Ligand Pharmaceuticals and developed by GSK. ITP affects as many as 5 in 100,000 children each year2 and is characterized by a low platelet count1. Up to 30% of affected children experience persistent disease for more than 6 months and are diagnosed ... Read more

Related support groups: Idiopathic (Immune) Thrombocytopenic Purpura, Promacta, Eltrombopag

FDA Approves New Indication for Promacta (eltrombopag) for Severe Aplastic Anemia

Posted 27 Aug 2014 by Drugs.com

London, UK – 26 August 2014 – GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the once-daily use of Promacta (eltrombopag) in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).1 SAA is a blood disorder where the bone marrow fails to make enough red blood cells, white blood cells, and platelets.2 Eltrombopag, an oral thrombopoietin (TPO) receptor agonist, works by helping to induce proliferation and differentiation of bone marrow stem cells to increase production of blood cells.1 “FDA approval of Promacta addresses a significant treatment need for this very rare but serious blood disorder in those who have failed current treatment options,” said Dr. Paolo Paoletti, President of Oncology, GSK. “Through colla ... Read more

Related support groups: Aplastic Anemia, Promacta, Eltrombopag

FDA Approves New Indication for Promacta (eltrombopag)

Posted 20 Nov 2012 by Drugs.com

LONDON, Nov. 19, 2012 – GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved Promacta for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.  Promacta is the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based therapy due to their low blood platelet counts.  Promacta in combination with interferon-based therapy has been shown to improve a patient's chance of achieving a sustained virologic response (SVR) or viral cure. There are limitations to the use of Promacta in patients suffering from chronic hepatitis C-associated thrombocytopenia.  These include: Promacta should not be used in an attempt to normalize platelet counts; Promacta should be used only in patients with ch ... Read more

Related support groups: Hepatitis C, Thrombocytopenia, Eltrombopag, Promacta, Hepatitis C, Chronic

FDA Announces Changes to Risk Strategy Requirements for Two Drugs to Treat Low Platelet Counts

Posted 7 Dec 2011 by Drugs.com

Includes labeling revisions for both drugs The approval of changes to the Risk Evaluation and Mitigation Strategies (REMS) for both Nplate (romiplostim) and Promacta (eltrombopag) was announced by the U.S. Food and Drug Administration. An FDA-initiated review of the current information has determined that while safety risks for both Nplate and Promacta still exist, certain restrictive requirements of the REMS programs are no longer necessary to ensure that the benefits of the drugs outweigh their risks. FDA will continue to monitor these drugs for safety risks. The agency has concluded that the long-term safety of Nplate and Promacta can be evaluated based on ongoing clinical trials, post-approval studies agreed to by both companies, and adverse event reports submitted to FDA. Major changes to the REMS for both products include: * Health care professionals, hospitals, specialty care ... Read more

Related support groups: Nplate, Romiplostim, Promacta, Eltrombopag

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Related Condition Support Groups

Idiopathic (Immune) Thrombocytopenic Purpura, Aplastic Anemia, Thrombocytopenia Idiopathic, Thrombocytopenia

Promacta Patient Information at Drugs.com