THOUSANDS OAKS, Calif. (
) -- The Food and Drug Administration has delayed approval of
osteoporosis drug Prolia because regulators need additional time to finalize a medication guide and risk-management plan for the drug, the company said Monday.
A delay in Prolia's approval was somewhat expected.
Amgen said the FDA, in its complete response letter, said no new clinical trials were necessary for Prolia's approval. The agency does, however, want additional information about Amgen's previously announced plans to monitor Prolia's safety once the drug is on the market.
The FDA and Amgen are also still working through a risk-management plan for Prolia which will be used to communicate the drug's risks and benefits to patients.
"We are confident that we can quickly respond to the FDA's requests for the treatment of postmenopausal osteoporosis indication and plan to do so in the near term," said Roger Perlmutter, Amgen's executive vice president of research and development, in a statement.
Amgen is seeking approval for Prolia as a treatment for women with post-menopausal osteoporosis. The company is counting on Prolia to re-ignite growth after a couple of years of flat earnings.
In the meantime, Citibank analyst Yaron Werber issued a research note Monday calling investor expectations for Prolia's commercial prospects in osteoporosis too high. "Based on our analyses, we believe that our below the Street estimates are more reasonable and that Street estimates need to be reduced. This will likely cap the near-term upside in the stock," he writes. Werber has a hold rating on Amgen with a $68 price target.
Amgen shares were down 2.5% to $59.76 in pre-market trading.
-- Reported by Adam Feuerstein in Boston
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