Active Substance: denosumab
Common Name: denosumab
ATC Code: M05BX04
Marketing Authorisation Holder: Amgen Europe B.V.
Active Substance: denosumab
Authorisation Date: 2010-05-26
Therapeutic Area: Osteoporosis, Postmenopausal Bone Resorption
Pharmacotherapeutic Group: Drugs for the treatment of bone diseases
Treatment of osteoporosis in postmenopausal women at increased risk of fractures. Prolia significantly reduces the risk of vertebral, non-vertebral and hip fractures.
Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.
What is Prolia?
Prolia is a solution for injection that contains the active substance denosumab. It is available in prefilled syringes or in vials, each of which contains 60 mg denosumab.
What is Prolia used for?
Prolia is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and have an increased risk of fracture (broken bones). Prolia reduces the risk of fractures in the spine and elsewhere in the body, including in the hip.
Prolia is also used to treat bone loss in men receiving treatment for prostate cancer that increases their risk of fracture. Prolia reduces the risk of fractures in the spine.
The medicine can only be obtained with a prescription.
How is Prolia used?
Prolia is given once every six months as a 60-mg injection under the skin in the thigh, abdomen (tummy) or back of the arm. During treatment with Prolia, the doctor should ensure that the patient is receiving calcium and vitamin-D supplements. Prolia can be given by someone who has been trained in how to give injections appropriately.
How does Prolia work?
The active substance in Prolia, denosumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body. Denosumab has been designed to attach to an antigen called RANKL, which is involved in activating osteoclasts, the cells in the body that are involved in breaking down bone tissue. By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts. This reduces the loss of bone and maintains bone strength, making fractures less likely to happen.
How has Prolia been studied?
The effects of Prolia were first tested in experimental models before being studied in humans.
Prolia has been compared with placebo (a dummy treatment) in two main studies involving a total of over 8,000 women with osteoporosis who had been through the menopause. In the first of these studies, the main measure of effectiveness was the number of women who had new fractures of the spine over three years.
The study also looked at the number of women who had fractures elsewhere in the body, including in the hip. In the second study, the women were receiving treatment for breast cancer and were considered to be at high risk of fracture. The main measure of effectiveness was the change in bone density (a measure of how strong the bones are) in the lumbar (lower) spine after a year of treatment.
Prolia has also been compared with placebo in one main study involving 1,468 men receiving treatment for prostate cancer who were at an increased risk of fracture. The main measure of effectiveness was the change in bone density of the lumbar spine after two years. This study also looked at the number of patients who had spine fractures over three years.
What benefit has Prolia shown during the studies?
Prolia was more effective than placebo at reducing fractures in women with osteoporosis who had been through the menopause. After three years, 2% of the women receiving Prolia had had a new spine fracture after three years compared with 7% of the women receiving placebo. Prolia was also more effective at reducing the number of women who had fractures elsewhere in the body, including in the hip. Women with breast cancer who took Prolia also had higher bone density in the lower spine after one year.
In men receiving treatment for prostate cancer, Prolia was more effective than placebo at treating bone loss. After two years, men who received Prolia had an increase in bone density in the lumbar spine that was 7% higher than in those who received placebo. In addition, after three years the risk of new spine fractures was lower in patients who received Prolia.
What is the risk associated with Prolia?
The most common side effects with Prolia (seen in between 1 and 10 patients in 100) are urinary-tract infection (infection of the structures that carry urine such as the bladder), upper-respiratory-tract infection (colds), sciatica (pain along the nerve at the back of the thighs), cataracts (clouding of the lens in the eye), constipation, rash, and pain in the arms or legs. Cataracts were seen mainly in men receiving treatment for prostate cancer. For the full list of all side effects reported with Prolia, see the package leaflet.
Prolia should not be used in people who may be hypersensitive (allergic) to the active substance or to any of the other ingredients. It must not be used in people with hypocalcaemia (low blood calcium levels).
Why has Prolia been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Prolia’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Other information about Prolia:
The European Commission granted a marketing authorisation valid throughout the European Union for Prolia to Amgen Europe B.V. on 26 May 2010. The marketing authorisation is valid for five years, after which it can be renewed.
Source: European Medicines Agency
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