Prolia™ (denosumab), a medicine for treatment of osteoporosis under review by the FDA, received approval today (May 28, 2010) for marketing in the European Union. For Amgen, the maker of Prolia™, this was the drug’s first approval for use. The approval was 2-fold:
1- for treatment of osteoporosis in postmenopausal women at increased risk of fractures and 2- for the treatment in men with prostate cancer receiving hormone treatment that causes bone loss and fractures.
Prolia™ works in a different way than the current FDA-approved osteoporosis medicines. Its unique mechanism of action specifically targets the regulator of the cells that break down bone called osteoclasts. Prolia™ stops the osteoclasts before they have a chance to get down to work breaking down bone and effectlvely reduces the risk of fracture.
Prolia™ is given by an injection just under the skin every six months. The approval was based on two 3-year clinical trials called the Fracture REduction Evaluation of Denosumab in Osteoporosis every six Months (FREEDOM) study and the HALT (Hormone Ablation Bone Loss Trial) study in men.
The FREEDOM study published in the New England Journal of Medicine included 7,808 postmenopausal women with osteoporosis. At the end of 3 years, the women receiving a shot of Prolia™ every six months had far fewer fractures then those given an inactive placebo shot. The researchers observed:
- 68% reduction in risk of suffering a spine fracture
- 40% reduction in risk of suffering a hip fracture
- 20% reduction in risk of suffering a nonspine fracture.
For men receiving hormone therapy that basically wipes out the hormone support of bone, bone loss can be rapid and severe putting survivors of prostate cancer at risk of devastating fractures. The HALT study published in the same issue of the New England Journal of Medicine evaluated percent change in bone mineral density at the lumbar spine in 1,468 men with metastatic prostate cancer undergoing hormone therapy called androgen deprivation therapy or ADT. At the end of two years, bone mineral density (BMD) increased in men taking Prolia™ shots every six months by 5.6%. At the end of three years, patients treated with Prolia™ experienced:
- 62% reduction in risk of suffering a spine fracture
- Increases of bone mineral density at the spine, hip and forearm
Prolia™ is a new option now for European citizens both women with osteoporosis and men with prostate cancer receiving hormonal therapy. The FDA is scheduled to respond to Amgen’s application for Prolia™ on July 25th 2010. Stay tuned for a new and exciting addition to the medicine chest for treatment of osteoporosis in the US.
-Diane L. Schneider, MD
Source: Amgen FDA Presentation, New England Journal of Medicine August 20, 2009 issue
Image: courtesy of dan /FreeDigitalPhotos.net