FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Bloo...( The new drug application for PROMA...),Health

The new drug application for PROMACTA was supported by the largest database of randomized clinical trial information on investigational therapies for chronic ITP patients. 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 PROMACTA affirms our commitment to hematology and oncology research, and demonstrates our dedication to developing truly innovative therapies for patients," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK. "PROMACTA is a significant step forward in helping patients and physicians better manage the challenges of chronic ITP."

The approval of PROMACTA was supported by an unanimous decision by the FDA's Oncology Drugs Advisory Committee (ODAC) on May 30, 2008, in which the panel voted, 16-0, that PROMACTA demonstrated a favorable risk-benefit profile for the short-term treatment of patients with chronic ITP.

GSK is 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 PROMACTA. 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 PROMACTA, while minimizing risks. 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. Knowledgeable con
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