What’s good for osteoporosis patients could also be good for the Thousand Oaks economy.        A study published Tuesday in the New England Journal of Medicine highlights denosumab, a new drug from local pharmaceutical giant Amgen, for the treatment of bone loss.      Amgen, which began in Thousand Oaks in 1980, discovers, develops and manufactures prescription drugs.      In 2007 the U.S. Food and Drug Administration made changes regarding how Amgen drugs Epogen and Aranesp were to be labeled, adversely affecting the company’s revenue. Amgen was forced to lay off almost 14 percent of its work force.      But if denosumab is approved by the FDA in October as Amgen hopes, the biotech company stands to gain a share of the $6billion to $8-billion market for osteoporosis medication, said Amgen spokesperson Kerry Beth Daly.      “We also have a strong pipeline of drugs coming up behind denosumab,” Daly said.      According to two studies investigating the safety and effectiveness of the new drug, denosumab, taken twice a year by injection, showed a 68 percent reduction in risk for fracture of the spine, a 20 percent reduction in nonspine fracture and a 40 percent reduction in risk for hip fracture in women with postmenopausal osteoporosis. It also reduced the incidence of new vertebral fractures by 62 percent in men with nonmetastatic prostate cancer who were undergoing androgen deprivation therapy.      The studies found risk factors were reduced in 7,800 women and 1,400 men.      “The promise of denosumab is very exciting because we believe in the potential of the new medicine to help many people with osteoporosis,” Daly said.      It is common for prostate cancer patients to receive hormone therapies that can lead to a decrease in bone mass and an increased risk of fractures.      “Bone loss and fractures are an important but often unrecognized nized problem for prostate cancer survivors. . . . Prevention of bone loss and fractures has been a key unmet medical need for men with prostate cancer,” said Matthew Smith, M.D., PhD, study author, associate professor of medicine and the director of genitourinary medical oncology at Massachusetts General Hospital Cancer Center.      In both studies, published in NEJM, patients receiving denosumab experienced significant increases in bone mineral density—associated with a greater than 60 percent reduction in vertebral fracture in both patient populations—compared to a placebo.

Fractures are common among postmenopausal women with osteoporosis.      “In this large international study, denosumab markedly increased bone mineral density and decreased the risk of fractures in many men receiving androgen deprivation therapy for prostate cancer. The efficacy of denosumab was apparent as early as one month and was sustained for three years,” Smith said.      Amgen scientists were able to develop the pathway for the drug from research they discovered in the 1990s when they were the first to identify the RANK Ligand pathway, a pivotal physiologic mechanism that controls bone remodeling, said Roger Perlmutter, M.D., PhD, executive vice president of research and development at Amgen.      In February the FDA accepted the Biologics License Application submitted by Amgen for denosumab. The FDA has provisionally approved the trade name Prolia, but it hasn’t yet approved the drug.       Amgen has also submitted marketing applications for use of denosumab in other countries.

An FDA advisory committee will meet today to review denosumab’s safety and discuss whether the drug’s benefits outweigh its risks. A briefing for that meeting noted the drug may increase risk of serious infections, new malignancies and the potential for tumor progression in patients with cancer.