FDA Panel To Review Proposed Osteoporosis Drug Aug 13
A Food and Drug Administration panel will review
Amgen Inc.'s (AMGN) proposed osteoporosis drug denosumab on Aug. 13, the agency
said Monday.
In a posting on the FDA's Web site, the FDA said its reproductive health drugs
advisory committee would meet to review denosumab, which would be sold under the
proposed brand name of Prolia. An advisory panel review was expected because
denosumab is considered a new chemical entity, and the FDA brings all new drugs
to advisory panels for review.
Amgen is seeking FDA approval for denosumab to treat or prevent osteoporosis
in postmenopausal women and to treat or prevent bone loss in patients undergoing
hormone therapy for breast or prostate cancer.
The FDA usually follows its panels' advice but is not required to. The agency
is expected to make a decision on the product in October.
Analysts have predicted that denosumab would quickly reach blockbuster status
of $1 billion or more in annual sales, which would offset declines of the
company's anti-anemia drugs Epogen and Aranesp.
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