NY Times
The Food and Drug Administration on Tuesday approved the sale of Amgen’s osteoporosis drug Prolia to help prevent fractures in postmenopausal women. Last week, the medicine received European approval.
The drug, known chemically as denosumab, is considered to be Amgen’s most important for its future. The F.D.A. decision was made nearly two months before the agency’s expected action date, July 25.
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, one out of every two women over age 50 will break a bone in their lifetime as a result of osteoporosis.
“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.”
In a pivotal study that was the basis for the approval, Prolia reduced the incidence of vertebral, nonvertebral, and hip fractures in postmenopausal women with osteoporosis.
Investors sent Amgen shares more than 3 percent higher in after-hours trading.
Prolia, which is given by injection once every six months, works to decrease the destruction of bone and increase bone mass and strength by inhibiting proteins that activate bone-destroying cells.
Analysts estimate that the product could draw annual global sales of $3.3 billion in 2014, according to Thomson Reuters. Shares of Amgen fell $1.02 , 0r 2 percent, to close at $50.76. They rose in after-hours trading.
The drug, known chemically as denosumab, is considered to be Amgen’s most important for its future. The F.D.A. decision was made nearly two months before the agency’s expected action date, July 25.
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, one out of every two women over age 50 will break a bone in their lifetime as a result of osteoporosis.
“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.”
In a pivotal study that was the basis for the approval, Prolia reduced the incidence of vertebral, nonvertebral, and hip fractures in postmenopausal women with osteoporosis.
Investors sent Amgen shares more than 3 percent higher in after-hours trading.
Prolia, which is given by injection once every six months, works to decrease the destruction of bone and increase bone mass and strength by inhibiting proteins that activate bone-destroying cells.
Analysts estimate that the product could draw annual global sales of $3.3 billion in 2014, according to Thomson Reuters. Shares of Amgen fell $1.02 , 0r 2 percent, to close at $50.76. They rose in after-hours trading.
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