Data from two phase 3 clinical studies evaluating romiplostim for the treatment of thrombocytopenia in ITP (studying pre- and post-splenectomy ITP) met both primary and secondary endpoints. Based on positive results from these studies, we submitted a BLA with the FDA for the treatment of thrombocytopenia in adult patients with chronic ITP in October 2007 and also completed regulatory filings for this indication in Europe, Canada, and Australia. The FDA has granted priority review for Nplate™ which will be discussed at the March 2008 ODAC meeting. We expect a regulatory decision in the first half of 2008.
We are also evaluating AMG 531 in myelodysplastic syndromes (“MDS”) and chemotherapy-induced thrombocytopenia (“CIT”). Phase 2 studies in each setting were initiated in 2006. The trials are currently ongoing and we continue to evaluate the safety and efficacy of AMG 531 in these settings.
This information is current as of February 27, 2008. Amgen’s product pipeline will change over time as molecules move through the drug development process, including progressing to market or failing in clinical trials, due to the nature of the development process. This description contains forward-looking statements that involve significant risks and uncertainties, including those discussed in Amgen’s most recent Form 10-K and in Amgen’s periodic reports on Form 10-Q and Form 8-K, and actual results may vary materially. Amgen is providing this information as of the date above and does not undertake any obligation to update any forward-looking statements contained in this table as a result of new information, future events or otherwise.
