Tuesday, The U.S. Food and Drug Administration said that it has approved Amgen Inc.'s (AMGN) Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures. Prolia is manufactured by Amgen Manufacturing Limited, a subsidiary of Thousand Oaks, California-based Amgen Inc.
Osteoporosis is a disease in which the bones become weak and are more likely to break. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, 80% of the people in the United States with osteoporosis are women. One out of every two women over age 50 will break a bone in their lifetime due to osteoporosis.
Prolia works to decrease the destruction of bone and increase bone mass and strength. An injection of Prolia is recommended once every six months. Prolia will cost $825 per 60 mg injection.
FDA said that the approval of Prolia provides another treatment option for postmenopausal women with osteoporosis who are susceptible to fractures. The safety and efficacy of Prolia in the treatment of postmenopausal osteoporosis was demonstrated in a three-year, randomized, double-blind, placebo-controlled trial.
Prolia, or denosumab, is a fully-human monoclonal antibody which has a unique mechanism of action. According to the company, it is the first and only approved therapy that specifically targets RANK Ligand, an essential regulator of osteoclasts, the cells that break down bone.
The FDA was scheduled to complete the review by July 25 of Amgen's application to market denosumab. The FDA decision comes nearly two months ahead of the scheduled date.
On 28th May, European Commission has granted marketing authorization for Prolia for the treatment of osteoporosis in postmenopausal women and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.
Prolia has been approved in all 27 European Union member states plus Norway, Iceland and Liechtenstein.
Amgen and GlaxoSmithKline (GSK) have announced, last year, a collaboration agreement to jointly commercialize Prolia for postmenopausal osteoporosis in Europe, Australia, New Zealand and Mexico once the product is approved in these countries.
As per the deal, Amgen will commercialize Prolia's postmenopausal osteoporosis and oncology indications in the U.S. and Canada and for all oncology indications in Europe and in other specified markets.
The company stated that Osteoporosis-related fractures were responsible for an estimated $19 billion in costs and by 2025 experts predict that these costs will rise to approximately $25 billion.
AMGN closed Tuesday's regular trading at $50.76 down $1.02 or 1.97% on a volume of 7.227 million shares on the Nasdaq, and in the after hour trading the stock price increased to $52.50 up $1.74 or 3.43%.
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