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Amgen's anti-osteoporosis drug, Prolia wins FDA approval

Although, the other options for osteoporosis are quite good, many women are unable to tolerate them, or have difficulty adhering to the daily regimen.

Amgen received approval from the U.S. Food and Drug Administration (FDA) for marketing the drug, Prolia, it has developed to treat and prevent bone loss in postmenopausal women who are at increased risk of fractures.

Amgen spokeswoman, Mary Klem stated, "We thank all the scientists, healthcare professionals and most importantly the patients who participated in the clinical trials, who made this first-in-class new treatment option possible."

It came close on the heels of European regulators giving the green light for marketing the drug on Friday, for treatment of postmenopausal women, and for men with prostate cancer who are at risk of fractures because of hormone treatments for their cancer.

Amgen’s clinical data demonstrated that Prolia reduced the incidence of spine fractures by 68 percent and hip fractures by 40 percent depending on bone location.

Drug approved after clinical trials
The drug was approved on the basis of a randomized, double-blind, placebo-controlled three-year pivotal study, involving 7,800 women.

According to the manufacturers, Prolia has a unique mechanism of action that targets RANK Ligand, an essential regulator of osteoclasts, the cells that break down bone.

Amgen’s clinical data demonstrated that Prolia reduced the incidence of spine fractures by 68 percent and hip fractures by 40 percent depending on bone location.

Around 4 percent patients treated with Prolia suffered serious skin infections as opposed to 3.3 percent in those who were administered placebos.

Attractive option compared to bisphosphonates
The current treatment for osteoporosis is bisphosphonates. However, nearly one in four women is unable to tolerate the therapy because of the crippling stomach pain.

In addition, it has to be taken on an empty stomach, and patients have to sit upright for half an hour before they eat or drink anything.

Prolia works just as effectively as bisphosphonates but without any adverse effects.

One advantage of the drug is that it is injected once every six months by a healthcare professional.

Although, the other options for osteoporosis are quite good, many women are unable to tolerate them, or have difficulty adhering to the daily regimen.

“Due to its prevalence, osteoporosis is a serious concern to public health,” Dr. Julie Beitz, director of an F.D.A. office of drug evaluation, said in a statement. “The approval of Prolia provides another treatment option for postmenopausal women with osteoporosis who are susceptible to fractures.”

The Company disclosed that Prolia will be launched in the markets within the next two weeks at a retail price of 825 per 60 milligram injection.

Following FDA’s announcement, Amgen’s shares surged by more than 4 percent in after-hours trading.