Info from FDA meeting about Nplate and MDS

[Birgitta-A]

Hi all,
Now the report from FDA meeting March 2008 about Nplate (Romiplostim, AMG 531) are available (pages 110-120). I don´t think the drug is OK for MDS patients.

http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4345t1-part2.pdf
Kind regards
Birgitta-A

[Wendy Beltrami]

Hi Brigitta,

I couldn't get that link to work, but I did find this power point presentation about the risk management plan that Amgen has proposed.

Is there actually a link to a report somewhere that talks more about the drug?


http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4345s1-05-FDA-Berkman_files/slide0001.htm


Wendy/mom to Grant

[Neil Cuadra]

Birgitta-A's link works, but you have to click it. If you copy the text you see in her post, and paste it into a web browser, it won't work because the forum system puts "..." in the display of long URLs. Clicking the link still goes to the full URL.

If anyone is still having trouble with the link above, click here (http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4345t1-part2.pdf) to get to the same PDF file. Also, make sure that your computer is set up for viewing PDFs by reviewing our Reading PDF files thread.