FDA Seeks Added Info On Amgen Bone Drug, Delays Decision
2009年10月19日 - 10:55PM
Dow Jones News
Amgen Inc. (AMGN) received a complete response letter from the
U.S. Food and Drug Administration, delaying the approval of
osteoporosis treatment denosumab as the agency seeks more
information.
It is unclear how long it will take for Amgen to meet the
requests, but Roger Perlmutter, executive vice president of
research and development, said in a statement that the company
plans to respond to the requests in the "near term."
Amgen shares traded down 2.5% to $59.80 in pre-market trading.
Many on Wall Street had expected such a delay for the drug, which
is key to Amgen's future growth, because regulators have a history
of missing deadlines and may want more time to analyze the safety
record of a new drug like denosumab.
Despite the delay, analyst generally expect the drug to
ultimately be approved.
A spokeswoman declined to comment beyond a press release issued
early Monday.
Amgen said the agency requested several items, including
information on the company's submitted post-market surveillance
plan.
The FDA isn't requiring any additional clinical trials prior to
completing the review of the drug, but it did request a new
clinical program to support approval for preventing postmenopausal
osteoporosis. The FDA has also requested all updated safety data
related to Prolia.
Denosumab has the support of six Phase III trials involving more
than 11,000 patients, with a relatively clean safety profile. Since
the approval submission earlier this year, data from two large
studies of denosumab's usefulness in preventing complications from
cancer's spread to bone have become available.
Amgen hasn't disclosed its regulatory filing plans for
preventing cancer-related skeletal complications, but a third study
is coming early next year and many expect approval in late
2010.
Amgen said the agency determined that denosumab needs a Risk
Evaluation and Mitigation Strategy, which must include a medication
guide, a communication plan, and a timetable for submission of
assessments of the plans. Amgen has already submitted materials for
such a program.
Denosumab is being reviewed for treating and preventing
postmenopausal osteoporosis, and bone loss caused by hormone
treatment in breast or prostate cancer. Amgen expects a separate
FDA response for the cancer-related application.
-By Thomas Gryta; Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com