GlaxoSmithKline's Revolade recommended for thrombocytopaenia in EU
by Mark Todoruk December 18, 2009 firstword.com
The EU's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for GlaxoSmithKline's Revolade (eltrombopag) for the treatment of reduced platelet count in adults with chronic idiopathic thrombocytopaenic purpura (ITP), the drugmaker announced.
The recommendation is for adult patients who have had their spleen removed, and who do not respond to other treatments. In addition, Revolade may also be considered as a second-line treatment for patients where surgery to remove their spleen is contraindicated.
GlaxoSmithKline said the opinion was supported by data that showed that previously treated patients with chronic ITP who were given Revolade "experienced significant increases in platelet counts, a reduction in the incidence of bleeding and an improvement in quality of life," compared with those who received placebo.
The product, already sold in the US as Promacta, was discovered through a research collaboration with Ligand. An estimate by some analysts predicts that the drug could attain sales of $260 million globally in 2012.