Denosumab, the experimental bone drug that’s key to Amgen’s future, got a mixed review from an FDA advisory committee yesterday. The panel voted in favor of using the drug to treat certain post-menopausal women with osteoporosis. And it said the drug could be used for some men being treated for prostate cancer. But the panel voted against using the drug to treat certain breast cancer patients, and against using it to treat post-menopausal women who are at risk for developing osteoporosis, the WSJ reports . Wall Street analysts seemed a bit surprised by denosumab’s so-so showing, but most said the drug fared well enough to stay on track. “We see little impact on denosumab’s commercial potential from less-than-expected panel outcome,” wrote Eun K. Yang of Jeffries. Treatment of post-menopausal osteoporosis is the biggest market for the drug, and approval of that indication is likely, Yang wrote. “While it wasn’t a perfect day for Amgen , the company did score

wins on the most important indications,” wrote Geoffrey C. Porges of Sanford Bernstein. Porges continues to project that worldwide sales of the drug will hit $5 billion in 2015, a figure he says is 15-30% above recent consensus. “Today’s FDA panel was surprisingly cautious ,” wrote Yaron Werber of Citi. Unlike several other analysts, Werber suggested the committee’s cautious stance “will likely lead to more modest adoption than expected” among post-menopausal women. In clinical trials, patients who received denosumab had a slightly higher rate of serious infections and certain cancers than patients who received placebo, the FDA said. But the difference wasn’t statistically significant, suggesting that the finding may have been a fluke. A popular class of existing osteoporosis drugs that includes Boniva, Fosamax and Reclast has its own risks, notably rare but serious cases of jaw decay.

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Analysts React to FDA Panel: ‘It Wasn’t a Perfect Day for Amgen’