Amgen says FDA will make a decision on denosumab in cancer-related bone injuries by November
THOUSAND OAKS, CA, USA | July 19, 2010 | Federal regulators will conduct a rapid review of Amgen’s treatment for bone damage suffered by cancer patients.
That means a decision on denosumab from the Food and Drug Administration will come within six months, or by Nov. 18, rather than the usual waiting period of 10 months.
The drug is an injection designed to strengthen bones. It is given once every six months.
Denosumab could be a huge seller for Amgen. Last month, the company began selling the drug under the name Prolia as a treatment for postmenopausal women who are at a high risk of bone fracture. Applying the treatment to cancer patients would increase the drug’s usage greatly.
The company said about 1.5 million cancer patients per year have tumors that spread to their bones, causing compression and fractures that must be treated with surgery or radiation. Amgen said it happens most often to patients with cancers of the prostate, lung, or breast.
Amgen Inc. is also seeking approval to market denosumab for the same use in Europe, Australia, Canada, and Switzerland, and is preparing to file for approval in Japan through a partnership with Daiichi Sankyo.
SOURCE: Amgen
Post Views: 35
Amgen says FDA will make a decision on denosumab in cancer-related bone injuries by November
THOUSAND OAKS, CA, USA | July 19, 2010 | Federal regulators will conduct a rapid review of Amgen’s treatment for bone damage suffered by cancer patients.
That means a decision on denosumab from the Food and Drug Administration will come within six months, or by Nov. 18, rather than the usual waiting period of 10 months.
The drug is an injection designed to strengthen bones. It is given once every six months.
Denosumab could be a huge seller for Amgen. Last month, the company began selling the drug under the name Prolia as a treatment for postmenopausal women who are at a high risk of bone fracture. Applying the treatment to cancer patients would increase the drug’s usage greatly.
The company said about 1.5 million cancer patients per year have tumors that spread to their bones, causing compression and fractures that must be treated with surgery or radiation. Amgen said it happens most often to patients with cancers of the prostate, lung, or breast.
Amgen Inc. is also seeking approval to market denosumab for the same use in Europe, Australia, Canada, and Switzerland, and is preparing to file for approval in Japan through a partnership with Daiichi Sankyo.
SOURCE: Amgen
Post Views: 35
