Romiplostim (AMG 531) for low platelets

[Birgitta-A]

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

[Marrowforums]

Amgen press release.

A number of Marrowforums members have expressed interest in romiplostim, formerly called AMG 531, and are looking forward to its approval.

[Birgitta-A]

Hi all members with thrombocytopenia,
Here is a link with results from a trial with Romiplostim in MDS patients: http://professional.cancerconsultant....aspx?id=39936
Kind regards
Birgitta

[Wendy Beltrami]

Just FYI,

Dr. Maciejewski from Cleveland Clinic has been approved for a pilot trial study for AA with Eltrombopag, the GlaxoSmithKline version of the new Romiplostim. There are many steps before this trial will start however, and he thinks that Romiplostim will probably be available first since Amgen is ahead of GSK in trials.

Don't know about all of you, but we are SO EXCITED about this.

Wendy/mom to Grant age 16
dx 12/4/98 AA

[Birgitta-A]

Hi Wendy,
Your hematologist is right - Romiplostim has had "fast track designation" many years and Promacta got fast track designation in Europe August 2007. I don´t think Promacta is approved as an orphan drug yet by FDA. I have difficulties to find relevant info at the FDA site. It is very important for a drug to get fast track designation (as a new treatment for uncommon diseases) because it makes the review time much shorter.
Kind regards
Birgitta