GSK announces submission to U.S. regulatory authorities for Promacta™ (eltrombopag) for severe aplastic anaemia
Issued: London UK
GlaxoSmithKline plc (LSE:GSK) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Promacta™ (eltrombopag) for the treatment of cytopenias (a reduction in blood cells) in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).
SAA is a rare disorder in which the bone marrow fails to make enough new blood cells. There are no approved therapies available for SAA patients unresponsive to IST. Of those patients unresponsive to initial IST, approximately 40% die from infection or bleeding within 5 years of their diagnosis.[i]
On 3 February 2014, GSK announced that the FDA granted Breakthrough Therapy designation for Promacta in SAA.
The sNDA application is based on the results from an open-label, Phase II National Institute of Health (NIH) study of eltrombopag in 43 heavily pre-treated SAA patients with an insufficient response to IST.
Eltrombopag—marketed as Promacta in the U.S. and as Revolade™ in Europe and other countries across the world—is not approved or licensed anywhere in the world for use in severe aplastic anaemia.
Eltrombopag is approved in 100 countries worldwide for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and in 43 countries worldwide for the treatment of 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.
For full Promacta U.S. Prescribing Information and Medication Guide and EU Patient Information Leaflet or Summary of Product Characteristics (SPC) for Revolade (eltrombopag) please visit http://www.gsk.com/products.html.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
Promacta and Revolade are registered trade marks of the GSK group of companies.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.
[i] Valdez JM, et al. Decreased Infection-Related Mortality and Improved Survival in Severe Aplastic Anemia in the Past Two Decades. Clinical Infectious Diseases 2011;52(6):726–735