New Injectable Osteoporosis Drug Prolia Gains FDA Approval

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Main Category: Bones / Orthopedics
Also Included In: Regulatory Affairs / Drug Approvals;  Menopause
Article Date: 03 Jun 2010 - 6:00 PDT

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Prolia, a new injectable drug to treat osteoporosis in postmenopausal women at high risk of fractures has been approved by the US Food and Drug Administration (FDA).

In a statement on its website on 1st June, the federal agency announced that approving Prolia, made by Amgen, offers postmenopausal women with osteoporosis at high risk of fractures another treatment option.

Osteoporosis is a disease that weakens bone and makes it more likely to break. Osteoporosis patients at high risk of fracture include those who have already experienced a fracture due to osteoporosis, or who have several risk factors for fracture, or who have tried other therapies but found they could either not tolerate them or they did not work.

The FDA's Dr Julie Beitz, director of the agency's Office of Drug Evaluation III, told the press that osteoporosis was a serious public health concern because of its prevalence.

Estimates from the National Institute of Arthritis and Musculoskeletal and Skin Diseases suggest that 80 per cent of Americans with osteoporosis are women and that half of women over the age of 50 will experience bone fracture due to osteoporosis.

In a three-year, randomized, double-blind, placebo-controlled trial involving nearly 8,000 postmenopausal women aged from 60 to 91, Prolia reduced the incidence of hip, vertebral and non-vertebral fractures in the participants with osteoporosis.

The most common side effects reported were musculoskeletal pain, back pain, pain in the extremities, high cholesterol levels, and urinary bladder infections.

Serious adverse reactions included skin infections and other reactions such as eczema, dermatitis and rashes, plus hypocalcaemia (not enough calcium in the blood).

Prolia, which is recommended to be given by injection once every six months, works by reducing the destruction and increasing the amount and strength of bone tissue. In so doing, it significantly suppresses bone turnover, and this may slow down the healing of fractures, help cause atypical fractures, and also help trigger a severe bone disease that affects the jaw (osteonecrosis of the jaw), warned the FDA.

Prolia is not the first injectable treatment to be approved for osteoporosis, but it is the first of its kind. Unlike the other injectable treatments which are sythesized from chemicals, Prolia is a biologic, a drug that is genetically engineered from human protein.

Dr. Ethel Siris, director of the Osteoporosis Center at Columbia University Medical Center, in New York, was one of the researchers who trialled the drug. She told CNN that Prolia is "a very potent agent and it is pretty clear that the reduction in fracture risk is quite robust".

Sources: FDA, CNN.

Written by: Catharine Paddock, PhD


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