Amgen's Bone Drug Prolia Wins Positive Review From U.K. Cost Regulators

Amgen Inc.’s bone-strengthening drug Prolia should be provided to women at risk of fractures who can’t take existing drugs, said a U.K. agency that advises the state-run National Health Service on cost-effective treatments.

Prolia, which increases bone mass and strength, should be used to prevent a first fracture from occurring and to ward off repeated broken bones, the National Institute for Health and Clinical Excellence said in a statement. The drug is injected twice a year and costs 183 pounds ($271) per treatment.

Older women who can’t take standard osteoporosis pills, including Merck & Co.’s Fosamax and Actonel, sold by Warner Chilcott Plc of Ardee, Ireland, should be eligible to receive Prolia, the agency said. GlaxoSmithKline Plc, based in London, will co-market the drug in Europe with Thousand Oaks, California-based Amgen. Analysts forecast sales of $2.9 billion for Prolia, known chemically as denosumab, by 2013.

“There was good quality evidence to show that denosumab is a useful addition to the treatment options available to prevent a first fracture in women at increased risk and also at preventing further factures in women who have already experienced one,” said Carole Longson, director of the health technology evaluation center at the agency known as NICE. “We hope that older women at increased risk of osteoporotic fractures who cannot take oral bisphosphonates will be considered for this drug to help prevent the misery of breaking a bone.”

The recommendation is preliminary and the agency is accepting comments. A final decision is expected later this year.

To contact the reporter on this story: Michelle Fay Cortez in London at mcortez@bloomberg.net