First new Osteoporosis Drug in over 10 years
Waiting approval to come to the market in Ireland
Osteoporosis is also known as brittle bone disease. I previously discussed the most common medicines used to treat osteoporosis including bisphosphonates. Today I discuss a new medication for severe osteoporosis.
Romosozumab (Evenity® 105mg Subcutaneous Injection) is a new monoclonal antibody treatment for severe osteoporosis and is the first new osteoporosis drug in over 10 years.
Romosozumab (Evenity®) received EU authorization by the European Medicines Agency in 2019. Romosozumab is not yet available in Ireland and is currently undergoing a cost benefit analysis as is normal for any new medication by the National Centre for Pharmacoeconomics (NCPE Ireland) on behalf of the HSE. The NCPE have requested more information form the manufacturer of Evenity® (Amgen) in advance of deciding on its approval in Ireland. Evenity® may be approved for payment by the HSE (PCRS) via the Hi-Tech Scheme in Ireland soon. It is still not available in England (NHS England continue a cost/benefit analysis) but is available in Scotland and Northern Ireland.
Romosozumab works by inhibiting sclerostin so increasing bone formation and decreasing bone resorption. It is reserved for use in postmenopausal women with severe osteoporosis meaning they are at high risk of fracture (i.e.) previously experienced a fracture and are at imminent risk of another within 24 months and in patients’ intolerant to other treatments or when other treatments have failed. There are early indications it may be more effective than denosumab in preventing non-spinal fractures including hip fractures.
In postmenopausal women, criteria for selecting romosozumab over bisphosphonates is one severe or two moderate low-trauma fractures (i.e.) same criteria as teriparatide. The recommended dose of romosozumab is 210 mg (administered as two subcutaneous injections of 105 mg) once monthly for 12 months. After 12 months, it should be followed by an alternative osteoporosis treatment such as denosumab or a bisphosphonate to allow continued protection as its benefits wear off quickly after stopping.
Who should avoid Romosozumab?
- History of stroke or heart attack
- Hypocalcaemia: An adequate intake of calcium and vitamin D before commencing romosozumab is advised as romosozumab can rarely cause a significant drop in calcium levels.
- Pregnancy or breast feeding: While it is only licensed for women post-menopause it may be prescribed by specialists for women pre-menopause
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