Amgen Statement on Business Wire® Erroneous Release of Nplate™ (romiplostim) News

On July 14, 2008, Business Wire® erroneously issued a press release relating to Nplate™ (romiplostim) approval on behalf of Amgen. This error was immediately identified and the press release was immediately withdrawn from circulation by both Amgen and Business Wire®. Nplate is under review by the FDA, and Amgen did not authorize the issuance of this press release prior to FDA approval.  Nplate has not been approved by FDA for marketing in the United States.

The FDA notified Amgen that they will not issue a decision on Nplate™ (romiplostim) by the PDUFA deadline of July 23, 2008. Amgen continues to work with the FDA to assist in the completion of the review process. We remain optimistic that a final decision will be made soon, but Amgen cannot speculate on the timing of the FDA’s response.