Amgen has received FDA approval for Nplate for the treatment of immune thrombocytopenic purpura (ITP). ITP is a bleeding condition--which affects about 60,000 people in the U.S.-- that causes the body to attack its own blood clotting cells. The injectable drug stimulates the body's bone marrow, which raises platelet count.
Back in March an expert panel unanimously recommended the drug and Amgen as been waiting for an approval since July. Analysts say the drug could earn between $66 million and $117 million in 2009.
- see Amgen's release [1]
- here's the WSJ report [2]
Related Articles:
FDA expected to act soon on Amgen's Nplate [3]
Experts to weigh in on Amgen's Nplate [4]
Amgen platelet therapy hits endpoint in Phase III [5]
Links:
[1] http://www.fiercebiotech.com/press-releases/amgen-amgn-release-fda-approves-nplate-tm-long-term-treatment-adult-chronic-itp-8-22-
[2] http://online.wsj.com/article/SB121943168850864273.html?mod=googlenews_wsj
[3] http://www.fiercebiotech.com/story/fda-expected-act-soon-amgen-s-nplate/2008-07-22
[4] http://www.fiercebiotech.com/story/experts-to-weigh-in-on-amgen-s-nplate/2008-03-12
[5] http://www.fiercebiotech.com/story/amgen-platelet-therapy-hits-endpoint-phase-iii/2007-12-10