Hi all members with thrombocytopenia,
Here is the third quarter 2007 report from Amgen about Romiplostim/AMG 531. At last they have filed to FDA for approval for ITP patients
but still not to the agencies in Europe, Canada and Australia
. There are clinical trials for MDS patients too
.
THOUSAND OAKS, Calif.--Oct. 24, 2007--Amgen
...Romiplostim (AMG 531): The Company has filed for FDA approval of romiplostim for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and expects to file in the E.U., Canada and Australia by the end of 2007. Romiplostim successfully met all key endpoints in its pivotal Phase 3 studies and data from both studies as well as a long-term extension study will be presented at the American Society of Hematology (ASH) later this year...
Kind regards
Birgitta