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FDA approves GSK blood platelet therapy
24 Nov 2008
Regulatory Affairs
The US Food and Drug Administration (FDA) has granted accelerated approval to a unique blood platelet medication, GlaxoSmithKline (GSK) has said.
Eltrombopag has been approved for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura (ITP) who have insufficiently responded to corticosteroids, immunoglobins or splenectomy.
GSK said the decision represents a "significant milestone" because eltrombopag - which will be marketed under the tradename Promacta - is the first oral thrombopoietin receptor agonist to be approved for adult patients with chronic ITP.
James Bussel, director of New York's Platelet Disorders Centre, said: "Preventing platelet destruction has always been the primary means of treating patients with ITP.
"Recent advances ... show that increasing the production of platelets may also play a significant role in treating this disorder."
Meanwhile GSK has announced it has signed an agreement with Shenzhen Neptunus Interlong Bio-Technique as a preliminary step in forming a joint venture between the two companies.
The joint venture company will seek to co-develop seasonal and pandemic influenza vaccines, firstly targeting strains specific to the China, Hong Kong and Macau regions.
Kobie says:
24 November 2008 at 11:24 AM