Amgen plans to respond to "complete response" soon
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Amgen will reply to FDA's "complete response" letter for Prolia in "the very near future," according to an update from CEO Kevin Sharer at the J.P. Morgan Healthcare Conference in San Francisco (1"The Pink Sheet," Jan. 14, 2010). Sharer also signaled that the development of a Risk Evaluation and Mitigation Strategy has been the challenge to moving forward. Amgen, which had hoped to resubmit its denosumab application before the end of the year, did not receive detailed instructions from FDA until mid-December as to what the agency expects in the resubmission, pushing the sponsor's response to the first quarter of 2010. Sharer noted that the letter includes detailed comments about "exactly" what FDA expects to see in the post-approval surveillance area. Analysts predict the re-submission will be granted a Class 1 designation and set in place a two-month review clock, lining up the drug for first quarter approval. Sharer also confirmed that Amgen will announce results from its prostate cancer skeletal-related events trial in the first quarter, which is the third of three pivotal Phase III trials that will constitute its oncology filing
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