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The Food and Drug Administration wants more information on denosumab before completing its review of the monoclonal antibody for the treatment and prevention of postmenopausal osteoporosis, the manufacturer, Amgen Inc., announced.
In a “Complete Response Letter,” the FDA requested more information on the design of Amgen's planned postmarketing surveillance program, and has asked the company to conduct a new clinical program for the postmenopausal osteoporosis prevention indication, according to an Amgen statement.
The agency also has requested updated safety data and has determined that a Risk Evaluation and Mitigation Strategy (REMS) is needed for the drug, the statement said. (The FDA requires REMS for drugs with safety issues to ensure that their benefits exceed their risks.) The company plans to respond quickly to the FDA's requests pertaining to the postmenopausal osteoporosis treatment indication.
In another statement reporting the company's third-quarter earnings, Amgen announced that it also had received a separate Complete Response Letter from the FDA regarding its approval application for denosumab for the treatment and prevention of bone loss caused by hormone ablation therapy in patients with breast or prostate cancer. In that letter, the agency requested more safety information in these populations, specifically results from “additional adequate and well-controlled clinical trials” showing that denosumab does not have detrimental effects on time-to-disease progression or overall survival in patients with breast cancer who are treated with an aromatase inhibitor, and in patients with prostate cancer who receive androgen deprivation therapy, according to the company. Amgen is reviewing both letters “and will work with the FDA to determine the appropriate next steps regarding these applications,” the company indicated.
At a meeting in August, an FDA advisory committee voted that the benefits of denosumab for treating postmenopausal osteoporosis outweighed its risks, but did not support use of the drug for other indications, including osteoporosis prevention, primarily because of concerns about its long-term safety. Denosumab, a human IgG2 monoclonal antibody, targets “an essential regulator” of osteoclasts, according to Amgen. It is also being studied for other conditions associated with bone loss, including rheumatoid arthritis, and for its potential to delay bone metastases. If approved, its trade name would be Prolia.
The Food and Drug Administration wants more information on denosumab before completing its review of the monoclonal antibody for the treatment and prevention of postmenopausal osteoporosis, the manufacturer, Amgen Inc., announced.
In a “Complete Response Letter,” the FDA requested more information on the design of Amgen's planned postmarketing surveillance program, and has asked the company to conduct a new clinical program for the postmenopausal osteoporosis prevention indication, according to an Amgen statement.
The agency also has requested updated safety data and has determined that a Risk Evaluation and Mitigation Strategy (REMS) is needed for the drug, the statement said. (The FDA requires REMS for drugs with safety issues to ensure that their benefits exceed their risks.) The company plans to respond quickly to the FDA's requests pertaining to the postmenopausal osteoporosis treatment indication.
In another statement reporting the company's third-quarter earnings, Amgen announced that it also had received a separate Complete Response Letter from the FDA regarding its approval application for denosumab for the treatment and prevention of bone loss caused by hormone ablation therapy in patients with breast or prostate cancer. In that letter, the agency requested more safety information in these populations, specifically results from “additional adequate and well-controlled clinical trials” showing that denosumab does not have detrimental effects on time-to-disease progression or overall survival in patients with breast cancer who are treated with an aromatase inhibitor, and in patients with prostate cancer who receive androgen deprivation therapy, according to the company. Amgen is reviewing both letters “and will work with the FDA to determine the appropriate next steps regarding these applications,” the company indicated.
At a meeting in August, an FDA advisory committee voted that the benefits of denosumab for treating postmenopausal osteoporosis outweighed its risks, but did not support use of the drug for other indications, including osteoporosis prevention, primarily because of concerns about its long-term safety. Denosumab, a human IgG2 monoclonal antibody, targets “an essential regulator” of osteoclasts, according to Amgen. It is also being studied for other conditions associated with bone loss, including rheumatoid arthritis, and for its potential to delay bone metastases. If approved, its trade name would be Prolia.
The Food and Drug Administration wants more information on denosumab before completing its review of the monoclonal antibody for the treatment and prevention of postmenopausal osteoporosis, the manufacturer, Amgen Inc., announced.
In a “Complete Response Letter,” the FDA requested more information on the design of Amgen's planned postmarketing surveillance program, and has asked the company to conduct a new clinical program for the postmenopausal osteoporosis prevention indication, according to an Amgen statement.
The agency also has requested updated safety data and has determined that a Risk Evaluation and Mitigation Strategy (REMS) is needed for the drug, the statement said. (The FDA requires REMS for drugs with safety issues to ensure that their benefits exceed their risks.) The company plans to respond quickly to the FDA's requests pertaining to the postmenopausal osteoporosis treatment indication.
In another statement reporting the company's third-quarter earnings, Amgen announced that it also had received a separate Complete Response Letter from the FDA regarding its approval application for denosumab for the treatment and prevention of bone loss caused by hormone ablation therapy in patients with breast or prostate cancer. In that letter, the agency requested more safety information in these populations, specifically results from “additional adequate and well-controlled clinical trials” showing that denosumab does not have detrimental effects on time-to-disease progression or overall survival in patients with breast cancer who are treated with an aromatase inhibitor, and in patients with prostate cancer who receive androgen deprivation therapy, according to the company. Amgen is reviewing both letters “and will work with the FDA to determine the appropriate next steps regarding these applications,” the company indicated.
At a meeting in August, an FDA advisory committee voted that the benefits of denosumab for treating postmenopausal osteoporosis outweighed its risks, but did not support use of the drug for other indications, including osteoporosis prevention, primarily because of concerns about its long-term safety. Denosumab, a human IgG2 monoclonal antibody, targets “an essential regulator” of osteoclasts, according to Amgen. It is also being studied for other conditions associated with bone loss, including rheumatoid arthritis, and for its potential to delay bone metastases. If approved, its trade name would be Prolia.