THE MIKIVERSE

From the New York Times

October 20, 2009
F.D.A. Says No, for Now, to an Amgen Bone Drug
By ANDREW POLLACK

Amgen has failed to win approval from the Food and Drug Administration, for now at least, for the bone-strengthening drug that the company has been counting on to propel its growth.

The company said Monday morning that the F.D.A. had instead asked for more information — though not new clinical trials — before it can approve the drug, denosumab. The drug is meant to be a treatment for osteoporosis, the bone-thinning disease, in women who have passed through menopause.

In recent days some Wall Street analysts had speculated that the F.D.A. would delay its decision on denosumab by 90 days past Monday’s deadline. Such a delay is not uncommon because the agency’s staff is stretched thin. But the F.D.A. instead issued a “complete response” letter, essentially a rejection, which could possibly delay approval well beyond 90 days.

Amgen’s stock fell more than 2 percent as trading opened.

Analysts have predicted that denosumab, which Amgen would sell under the name Prolia, could reach sales of at least $1 billion a year, and possibly much more. Amgen needs a hit product because sales of Aranesp, its flagship drug for anemia, have been hurt by safety concerns. And sales of its other big-selling drugs have slowed.

In a news release Monday morning, Amgen said the F.D.A. had asked for several items before it could approve denosumab to treat osteoporosis, including more information on the studies the company would perform after the drug is approved. The agency is also still discussing Amgen’s plans for limiting the risks from the drug’s use.

However, the company said, the F.D.A. did not ask for more clinical trials, which would have meant a much longer delay.

“We are confident that we can quickly respond to the F.D.A.’s request for the treatment of postmenopausal osteoporosis indication and plan to do so in the near term,” Dr. Roger M. Perlmutter, the company’s executive vice president for research and development, said in a statement.

Analysts generally said they expected Amgen would be able to satisfy the F.D.A.’s requirements fairly soon.

Geoffrey Meacham of JPMorgan said the F.D.A.’s request “doesn’t look onerous,” and he predicted the drug could be approved by the first quarter of 2010. Joshua Schimmer of Leerink Swann predicted a delay of five to 10 months, which would mean approval around the middle of next year.

But while Amgen could win approval next year for treatment of osteoporosis, it will be harder to win approval for the prevention of the disease. The company said Monday that the F.D.A. had asked for another clinical trial testing the use of the drug to prevent the bone disease in women who have less severe bone weakness and are not at as severe a risk of fractures as those with osteoporosis.

In August, an advisory committee to the F.D.A. had voted 15-0 in August in favor of approval of denosumab for the treatment of osteoporosis, but 12-3 against approval for the prevention of osteoporosis.

Amgen had also applied for approval to sell denosumab as a treatment for the bone loss caused by the hormone suppression therapies used to treat breast cancer and prostate cancer. About 10 million women in the United States have osteoporosis, and an additional 34 million are at risk for it, according to the National Osteoporosis Foundation.

The main drugs now used to treat the condition are bisphosphonates — including Fosamax, Actonel and Boniva — which are taken as pills every day, or every week or every month. But those drugs can be hard to tolerate, meaning many patients stop taking them after a while.

Denosumab, which works through a mechanism discovered in Amgen’s own laboratories, is a protein called a monoclonal antibody. It would be given by an injection every six months, which could make it easier for patients to remain on therapy.

But insurers are likely to require that patients try bisphosphonates first, particularly since generic versions of Fosamax are now available and likely to be far less expensive than denosumab.