Amgen Inc. pledged on Thursday to closely monitor the long-term safety of its novel osteoporosis injection as U.S. advisers weighed the future of the company's most important experimental drug.
Denosumab is seen as a potential blockbuster and the key to growth at the world's largest biotechnology company after safety concerns hit its flagship anemia medicines , Reuters reports.
However, Amgen is seeking to have the product approved to treat bone loss associated with post-menopausal osteoporosis and certain treatments for breast and prostate cancer.
While the FDA is not bound to the recommendations of its advisory panels, it generally follows them. Amgen watchers are anticipating the agency will approve the drug in October , MarketWatch reports.
Meanwhile, professor Graham Russell, of Oxford University, said: 'These results suggest that denosumab offers an important new approach to prevention of fractures in women with postmenopausal osteoporosis.'
He added that because the drug was administered by an injection it would be more convenient for patients who had problems taking oral therapy , Daily Mail reports.