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news.GlaxoSmithKline has announced that the FDA granted accelerated approval for Promacta for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
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The approval is said to be a significant milestone for eltrombopag and the immune thrombocytopenic purpura (ITP) community, as eltrombopag is the first oral thrombopoietin receptor agonist approved for adult patients with chronic ITP. GlaxoSmithKline (GSK) expects eltrombopag to be available next week.
The indication is based on data from two pivotal studies in the short-term treatment and one ongoing long-term treatment study of patients with chronic ITP. The approval of eltrombopag was supported by a unanimous decision by the FDA’s Oncology Drugs Advisory Committee on May 30, 2008, in which the panel voted, 16-0 that eltrombopag demonstrated a favorable risk-benefit profile for the short-term treatment of patients with chronic ITP.
GSK is also launching Promacta Cares, a single source of information, education and support for healthcare professionals and patients. Prescribers and pharmacies must enroll in Promacta Cares before they can prescribe or dispense eltrombopag. Similarly, patients are required to enroll in Promacta Cares before they can receive the drug.
This program was created in accordance with the FDA’s requirements to help assure the appropriate and safe use of eltrombopag, while minimizing risks, including the risk of hepatoxicity. Promacta Cares is part of an ongoing collaboration between GSK and the FDA to provide a format for appropriate additional data collection.
Additionally, Promacta Cares has an optional component; reimbursement support for the uninsured and under-insured as part of GSK’s ongoing commitment to providing needed medicines to those who may benefit from assistance.