New Drug for Osteoporosis May Face FDA Scrutiny

Amgen's new drug for osteoporosis, Denosumab, may have difficulty getting Food and Drug Administration (FDA) approval in its initial attempt due to a higher incidence of infections compared with placebos in some patients.

A new drug for osteoporosis is constantly being sought due to this disorder’s growing prevalence among both women and men, and Denosumab is a high tech entrant into the battle. Denosumab is a human monoclonal antibody used to target Receptor Activator for Nuclear Factor ? B Ligand (RANKL), which is a protein that signals bone removal. By neutralizing this protein, the hope is that Denosumab may reduce bone loss in osteoporosis patients.

Denosumab is also currently a focus of study to determine its benefit in a host of other conditions, such as osteopenia, cancer metastases to the bone, treatment-induced bone demineralization, rheumatoid arthritis, and multiple myeloma.

Michael Lewiecki, MD, clinical assistant professor of medicine, University of New Mexico School of Medicine, says of this new drug for osteoporosis, "The two-year results showed the continued effect of Denosumab in increasing bone mineral density in postmenopausal patients with low bone mass. "When administered twice yearly, Denosumab may offer patients an effective alternative for both the prevention of, and treatment for, osteoporosis.

The Compelling Need for a New Drug for Osteoporosis

Bone loss and osteoporosis affect approximately 44 million Americans, and are significant clinical and economic burdens on our healthcare system. More than half of people over the age of 50 years have already lost a significant amount of bone strength and density, and have been diagnosed with osteoporosis. About 10 million people are estimated to have some degree of the brittle bone disease, and nearly 34 million more are believed to suffer from low bone density, which places them at an increased risk for developing osteoporosis. These staggering figures are compelling doctors and researchers to look for a new drug for osteoporosis. While it is true that osteoporosis affects more women than men, of the estimated 10 million Americans believed to suffer from the disease, two million of them are men. Additionally, 50% of women and 25% of men over the age of 50 will experience an osteoporosis-related bone fracture during their lifetime. According to recent European estimates, nearly 3.8 million individuals have experienced a bone fracture directly related to this crippling disease.

In the face of the obvious dangers of osteoporosis, and until a safer, more effective new drug for osteoporosis is discovered, many sufferers are relying on alternative treatment routes, such as avoiding high protein diets, introducing high calcium foods into the diet, and reinforcing dietary sources with calcium supplements.