NAPSR News: GSK Scores New Approval for Promacta® to Treat Bone Marrow Disorder

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WASHINGTON - Aug. 27, 2014 - PRLog -- The U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Promacta® developed by GlaxoSmithKline (GSK) to treat a rare bone marrow disorder. The once-daily use of Promacta® (eltrombopag) is intended for patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST). SAA is a blood disorder where the bone marrow fails to make enough red blood cells, white blood cells, and platelets. Eltrombopag is an oral thrombopoietin-receptor agonist and functions as a helper to induce proliferation and differentiation of bone marrow stem cells thus increasing the production of blood cells.

“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 collaboration with the National Institutes of Health, whose studies demonstrate the potential for Promacta to achieve a haematologic response in at least one lineage – red blood cells, platelets, or white blood cells – patients now have a treatment option where one didn’t previously exist.”

Approval was based on the results of a single-arm, single-centre, open-label Phase II study (09-H-0154) conducted by the National Heart, Lung and Blood Institute (NHLBI) at the National Institutes of Health (NIH) involving 43 patients . The study demonstrated a haematologic response in SAA patients treated with the drug who had not responded to immunosuppressive therapy (IST).

Promacta®  is already approved to treat chronic immune (idiopathic) thrombocytopenia (ITP) when either corticosteroids, immunoglobulins or surgery to remove the spleen have not worked well enough and to treat low blood platelet counts in people with chronic hepatitis C virus (HCV) infection before and during treatment with interferon.

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Tags:Naprx, Napsrx, CNPR Certification Program, Pharmaceutical Sales, Napsr
Industry:Health, Medical
Location:Washington - District of Columbia - United States
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