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Idiopathic (Immune) Thrombocytopenic Purpura News

Related terms: Immune Thrombocytopenic Purpura, ITP

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

Posted 7 days ago 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 8 days ago 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, Promacta, Thrombotic Thrombocytopenic Purpura, 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

Promacta Approved for Rare Blood Disorder

Posted 24 Nov 2008 by Drugs.com

MONDAY, Nov. 24 – The U.S. Food and Drug Administration has approved Promacta (eltrombopag) to treat a rare condition in which the body attacks its own blood platelets. Chronic immune thrombocytopenic purpura (ITP) affects about 60,000 people in the United States, according to a news release from the drug's maker, GlaxoSmithKline. ITP patients often bleed from small blood vessels, resulting in bruising, nosebleeds and in rare cases, bleeding from the brain. The drug's labeling will include the FDA's most serious advisory, a so-called "black-box warning," highlighting Promacta's risk of damaging the liver. According to the Associated Press, the FDA delayed an approval decision on Promacta in June, citing the drug's liver toxicity. People taking Promacta must have regular serum liver tests, Glaxo said. Promacta will be available through a restricted distribution program, in which only ... Read more

Related support groups: Idiopathic (Immune) Thrombocytopenic Purpura

Bone Marrow Treatment Approved for Rare Bleeding Disorder

Posted 22 Aug 2008 by Drugs.com

FRIDAY, Aug. 22 – The U.S. Food and Drug Administration has approved Nplate (romiplostim), a drug that stimulates bone marrow to make needed platelets in people with a rare bleeding disorder called immune thrombocytopenic purpura (ITP). The disorder, affecting about 140,000 people in the United States, causes a low count of platelets, a component that helps blood clot. In people with chronic ITP, it's believed the body's own immune system destroys platelets, and the bone marrow is unable to produce enough platelets to compensate. People with ITP tend to bruise easily and are at risk for life-threatening bleeding, the FDA said in a news release. During six months of clinical testing involving 125 people with ITP, those who received Nplate had significantly higher platelet counts than those who didn't get the drug, the agency said. Possible risks from taking the drug include fibrous ... Read more

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prednisone, cortisone, dexamethasone, triamcinolone, cyclosporine, azathioprine, Decadron, rituximab, Kenalog-40, view more... RhoGAM, interferon alfa-2b, Nplate, Gammagard, Neoral, Promacta, Gamunex, immune globulin intravenous, Deltasone, Sandoglobulin, Octagam, Flebogamma, Rhophylac, Carimune, Intron A, Sterapred, eltrombopag, romiplostim, Privigen, Gengraf, MICRhoGAM, WinRho SDF, Sandimmune, Liquid Pred, Dexpak Taperpak, Adrenocot LA, rho (d) immune globulin, Gamunex-C, Adrenocot, Liberim D, Carimune NF, Sterapred DS, Polygam S / D, Dexone, HypRho-D Mini-Dose, BayRHo-D, Mini-Gamulin Rh, BayRHo-D Full Dose, BayRHo-D Mini-Dose, D-Gam Anti-D, Partobulin SDF, Dalalone LA, Decaject LA, Decaject, Gammaplex, Gammar IV, Zema Pak, Gamulin Rh, Dalalone DP, Gamimune, HyperRHO S / D Mini-Dose, Dexamethasone Intensol, Baycadron, Dalalone, HyperRHO S / D Full Dose, Prednicen-M, Dexacort-LA, De-Sone LA, Dexasone, Dexasone LA, Primethasone, Dexone LA, Solurex, Dexacen-4, Panglobulin NF, immune globulin intravenous and subcutaneous, Hexadrol, Decadron-LA, Solurex LA, Dexacorten, Medidex, Venoglobulin-S 10%, Venoglobulin-S 5%, Gammar-P IV, Gamimune N 5%, Panglobulin, Gamimune N 10%, Gammagard S / D, Clinacort, Meticorten, Medidex LA, Orasone, Prednicot, Cortone Acetate, Iveegam En