Amgen Canada announced that Health Canada has approved Prolia(TM) (denosumab), the first and only RANK Ligand inhibitor, for the treatment of postmenopausal women with osteoporosis at high risk for fracture
MISSISSAUGA, ON, CANADA | September 8, 2010 | Amgen Canada today announced that Health Canada has approved Prolia(TM) (denosumab), the first and only RANK Ligand inhibitor, for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Unlike existing therapies, Prolia is a new, targeted therapy that treats osteoporosis by blocking the RANK Ligand protein to stop the cells that breakdown bone while increasing bone mass and bone strength, reducing the chance of breaking bones (fracture) at the hip, spine and non-spine sites measured in clinical studies.
"The approval of Prolia marks an exciting advancement for the treatment of postmenopausal osteoporosis," said Dr. Aliya Khan, Professor of Clinical Medicine, Divisions Endocrinology and Geriatrics at McMaster University. "Unlike any other treatment, Prolia decreases the formation of bone removing cells, preventing bone loss and increasing bone mass, offering Canadian women a new choice for preventing fracture."
Bones should not break without significant trauma. However, as osteoporosis is a silent disease, it often goes unnoticed and left untreated, putting one in four women over the age of 50 at risk of fracture.(1) Fracture can lead to reduction or loss of mobility, decreased independence and increased risk of death.(2-3) While osteoporosis can be treated, there are a number of challenges with current treatment options, which may lead to some women stopping treatment.(4)
"One of the major roadblocks to treating women with osteoporosis is the challenge some women face when it comes to taking their treatments as prescribed by their doctors," said Dr. Famida Jiwa, acting President & CEO, Osteoporosis Canada. "Many women stop taking their treatments because of side-effects or difficulty with keeping to their medication schedule. The danger, however, is that stopping treatment puts people at risk of bone loss and fracture."
Prolia is a novel, targeted treatment for postmenopausal women with osteoporosis at high risk for fracture, which offers physicians and patients a new treatment choice. Prolia is given by a trained healthcare professional once every six months as an injection under the skin, in contrast with current oral bisphosphonate therapies that have daily, weekly or monthly dosing regimens.
"I had significant improvement on Prolia, specifically in my spine," said Iris Richman, osteoporosis patient from London, Ontario. "Prolia has simplified my life as it’s a convenient injection twice a year."
"The approval of Prolia marks the introduction of a new class of medicine in more than a decade for the treatment of postmenopausal osteoporosis," said Clive Ward-Able, Executive Director, Research & Development, Amgen Canada. "Prolia is a unique, targeted treatment offering physicians and patients a new treatment option to reduce fracture risk with dosing once every six months."
Clinical Trial Results
Health Canadas approval of Prolia is based on the pivotal Phase 3 FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every six Months) study involving 7,808 postmenopausal women with osteoporosis. In this study comparing Prolia to placebo, treatment with Prolia resulted in greater bone mass, stronger bones, and significant reduced risk for fractures at the spine, hip and other sites measured at three years.(5) Specifically, Prolia demonstrated (relative to placebo):
– 68% reduction in incidence of vertebral (spine) fractures
– 40% reduction in incidence of hip fractures
– 20% reduction in incidence of non-vertebral (non-spine) fractures
– Significant bone mineral density increases at all sites measured (8.8 per cent at the lumbar spine, 6.4 per cent at the total hip, and 5.2 per cent at the femoral neck).(6)
Prolia is now available to patients in Canada with a prescription from a physician.
About Prolia(TM) (denosumab)
Prolia is the first and only approved therapy that specifically targets RANK Ligand, an essential mediator of osteoclast (the cells that break down bone) formation, function and survival. Prolia is approved by Health Canada for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia reduces the incidence of vertebral, nonvertebral and hip fractures.
Prolia is the trade name for denosumab in postmenopausal osteoporosis for which it is administered once every six months subcutaneously as a 60 mg dose pre-filled syringe.
Important Safety Information
The most common adverse events with Prolia as observed in the clinical trial were back pain (34.7 per cent in Prolia patients vs 34.6 per cent in patients receiving placebo), arthralgia (joint pain; 20.2 per cent in Prolia patients and patients receiving placebo) and hypertension (15.8 per cent in Prolia patients vs 16.4 per cent in patients receiving placebo).(7) The most common serious adverse events observed in the clinical trial were osteoarthritis (1.6 per cent in Prolia patients vs. 2.0 per cent in patients receiving placebo), atrial fibrillation (0.9 per cent in Prolia patients and patients receiving placebo) and pneumonia (0.9 per cent in Prolia patients and patients receiving placebo).(8)
Prolia is contraindicated for patients who are hypersensitive to the drug or any component of the product and those with hypocalcemia. Adequate intake of calcium and vitamin D is important in all patients. Hypocalcemia should be corrected with calcium and vitamin D prior to initiating Prolia. Calcium levels should be monitored in patients predisposed to hypocalcemia. Patients should be advised to seek prompt medical attention if they develop signs or symptoms of hypocalcemia (e.g., paresthesias or muscle spasms.).(9) Overall skin infections leading to hospitalization, including cellulitis and erysipelas were reported more frequently in the Prolia (0.4 per cent) group than in the placebo (seek prompt medical attention if signs or symptoms of severe infection including cellulitis and erysipelas present. The benefit-risk profile should be considered in patients taking immunosuppressant agents before treating with Prolia.(10) Epidermal and dermal events (e.g. dermatitis, eczema and rash) occurred at a significantly higher rate in the Prolia (10.8 per cent) group compared to the placebo (8.2 per cent) group. Consider discontinuing Prolia if severe symptoms develop.(11) Osteonecrosis of the jaw (ONJ) has been reported in patients treated with denosumab or bisphosphonates. A dental examination with appropriate preventative dentistry should be considered in patients with risk factors for ONJ. If ONJ occurs during treatment, guide the management plan of each patient based on individual benefit/risk evaluation.(12) Treatment with Prolia resulted in significant suppression of bone remodeling. The significance of these findings and the effect of long-term treatment with Prolia are unknown. Monitor patients for ONJ, atypical fractures and delayed fracture healing.(13)
Amgen continues to collect safety data on an ongoing basis through extensive studies and post-marketing pharmacovigilance.
About Osteoporosis
Osteoporosis is a chronic and debilitating disease characterized by low bone mass and deterioration of bone tissue.(14) Osteoporosis affects nearly two million Canadians(15) and is a global problem that is increasing in significance as the population of the world both increases and ages. It is known as the ‘silent thief’ because bone loss often occurs without symptoms.(16) At least 80 per cent of fractures in people over 60 years of age are related to osteoporosis,(17) and the most common sites of osteoporosis-related fractures are the hip, spine and wrist.(18) Despite the availability of existing osteoporosis treatments, the annual incidence of fractures continues to be substantial.(19),(20), (21) Eighty per cent of hip fractures are related to osteoporosis.(22) Within six months of suffering a hip fracture, almost one out of every four women wil die of complications related to the fracture.(23) Of those who survive, half will suffer from disability.(24) The lifetime risk of hip fracture is greater (one in six) than the one in nine lifetime risk of developing breast cancer.(25)
For more information about osteoporosis, visit healthandbone.ca.
About Amgen
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new sciences promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve peoples lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.ca.
SOURCE: Amgen
Post Views: 106
Amgen Canada announced that Health Canada has approved Prolia(TM) (denosumab), the first and only RANK Ligand inhibitor, for the treatment of postmenopausal women with osteoporosis at high risk for fracture
MISSISSAUGA, ON, CANADA | September 8, 2010 | Amgen Canada today announced that Health Canada has approved Prolia(TM) (denosumab), the first and only RANK Ligand inhibitor, for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Unlike existing therapies, Prolia is a new, targeted therapy that treats osteoporosis by blocking the RANK Ligand protein to stop the cells that breakdown bone while increasing bone mass and bone strength, reducing the chance of breaking bones (fracture) at the hip, spine and non-spine sites measured in clinical studies.
"The approval of Prolia marks an exciting advancement for the treatment of postmenopausal osteoporosis," said Dr. Aliya Khan, Professor of Clinical Medicine, Divisions Endocrinology and Geriatrics at McMaster University. "Unlike any other treatment, Prolia decreases the formation of bone removing cells, preventing bone loss and increasing bone mass, offering Canadian women a new choice for preventing fracture."
Bones should not break without significant trauma. However, as osteoporosis is a silent disease, it often goes unnoticed and left untreated, putting one in four women over the age of 50 at risk of fracture.(1) Fracture can lead to reduction or loss of mobility, decreased independence and increased risk of death.(2-3) While osteoporosis can be treated, there are a number of challenges with current treatment options, which may lead to some women stopping treatment.(4)
"One of the major roadblocks to treating women with osteoporosis is the challenge some women face when it comes to taking their treatments as prescribed by their doctors," said Dr. Famida Jiwa, acting President & CEO, Osteoporosis Canada. "Many women stop taking their treatments because of side-effects or difficulty with keeping to their medication schedule. The danger, however, is that stopping treatment puts people at risk of bone loss and fracture."
Prolia is a novel, targeted treatment for postmenopausal women with osteoporosis at high risk for fracture, which offers physicians and patients a new treatment choice. Prolia is given by a trained healthcare professional once every six months as an injection under the skin, in contrast with current oral bisphosphonate therapies that have daily, weekly or monthly dosing regimens.
"I had significant improvement on Prolia, specifically in my spine," said Iris Richman, osteoporosis patient from London, Ontario. "Prolia has simplified my life as it’s a convenient injection twice a year."
"The approval of Prolia marks the introduction of a new class of medicine in more than a decade for the treatment of postmenopausal osteoporosis," said Clive Ward-Able, Executive Director, Research & Development, Amgen Canada. "Prolia is a unique, targeted treatment offering physicians and patients a new treatment option to reduce fracture risk with dosing once every six months."
Clinical Trial Results
Health Canadas approval of Prolia is based on the pivotal Phase 3 FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every six Months) study involving 7,808 postmenopausal women with osteoporosis. In this study comparing Prolia to placebo, treatment with Prolia resulted in greater bone mass, stronger bones, and significant reduced risk for fractures at the spine, hip and other sites measured at three years.(5) Specifically, Prolia demonstrated (relative to placebo):
– 68% reduction in incidence of vertebral (spine) fractures
– 40% reduction in incidence of hip fractures
– 20% reduction in incidence of non-vertebral (non-spine) fractures
– Significant bone mineral density increases at all sites measured (8.8 per cent at the lumbar spine, 6.4 per cent at the total hip, and 5.2 per cent at the femoral neck).(6)
Prolia is now available to patients in Canada with a prescription from a physician.
About Prolia(TM) (denosumab)
Prolia is the first and only approved therapy that specifically targets RANK Ligand, an essential mediator of osteoclast (the cells that break down bone) formation, function and survival. Prolia is approved by Health Canada for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia reduces the incidence of vertebral, nonvertebral and hip fractures.
Prolia is the trade name for denosumab in postmenopausal osteoporosis for which it is administered once every six months subcutaneously as a 60 mg dose pre-filled syringe.
Important Safety Information
The most common adverse events with Prolia as observed in the clinical trial were back pain (34.7 per cent in Prolia patients vs 34.6 per cent in patients receiving placebo), arthralgia (joint pain; 20.2 per cent in Prolia patients and patients receiving placebo) and hypertension (15.8 per cent in Prolia patients vs 16.4 per cent in patients receiving placebo).(7) The most common serious adverse events observed in the clinical trial were osteoarthritis (1.6 per cent in Prolia patients vs. 2.0 per cent in patients receiving placebo), atrial fibrillation (0.9 per cent in Prolia patients and patients receiving placebo) and pneumonia (0.9 per cent in Prolia patients and patients receiving placebo).(8)
Prolia is contraindicated for patients who are hypersensitive to the drug or any component of the product and those with hypocalcemia. Adequate intake of calcium and vitamin D is important in all patients. Hypocalcemia should be corrected with calcium and vitamin D prior to initiating Prolia. Calcium levels should be monitored in patients predisposed to hypocalcemia. Patients should be advised to seek prompt medical attention if they develop signs or symptoms of hypocalcemia (e.g., paresthesias or muscle spasms.).(9) Overall skin infections leading to hospitalization, including cellulitis and erysipelas were reported more frequently in the Prolia (0.4 per cent) group than in the placebo (seek prompt medical attention if signs or symptoms of severe infection including cellulitis and erysipelas present. The benefit-risk profile should be considered in patients taking immunosuppressant agents before treating with Prolia.(10) Epidermal and dermal events (e.g. dermatitis, eczema and rash) occurred at a significantly higher rate in the Prolia (10.8 per cent) group compared to the placebo (8.2 per cent) group. Consider discontinuing Prolia if severe symptoms develop.(11) Osteonecrosis of the jaw (ONJ) has been reported in patients treated with denosumab or bisphosphonates. A dental examination with appropriate preventative dentistry should be considered in patients with risk factors for ONJ. If ONJ occurs during treatment, guide the management plan of each patient based on individual benefit/risk evaluation.(12) Treatment with Prolia resulted in significant suppression of bone remodeling. The significance of these findings and the effect of long-term treatment with Prolia are unknown. Monitor patients for ONJ, atypical fractures and delayed fracture healing.(13)
Amgen continues to collect safety data on an ongoing basis through extensive studies and post-marketing pharmacovigilance.
About Osteoporosis
Osteoporosis is a chronic and debilitating disease characterized by low bone mass and deterioration of bone tissue.(14) Osteoporosis affects nearly two million Canadians(15) and is a global problem that is increasing in significance as the population of the world both increases and ages. It is known as the ‘silent thief’ because bone loss often occurs without symptoms.(16) At least 80 per cent of fractures in people over 60 years of age are related to osteoporosis,(17) and the most common sites of osteoporosis-related fractures are the hip, spine and wrist.(18) Despite the availability of existing osteoporosis treatments, the annual incidence of fractures continues to be substantial.(19),(20), (21) Eighty per cent of hip fractures are related to osteoporosis.(22) Within six months of suffering a hip fracture, almost one out of every four women wil die of complications related to the fracture.(23) Of those who survive, half will suffer from disability.(24) The lifetime risk of hip fracture is greater (one in six) than the one in nine lifetime risk of developing breast cancer.(25)
For more information about osteoporosis, visit healthandbone.ca.
About Amgen
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new sciences promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve peoples lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.ca.
SOURCE: Amgen
Post Views: 106
