New osteoporosis medication approved for use in the UK
18 Oct 2019
We are pleased that a new osteoporosis medication called romosozumab, used to treat post-menopausal women at high risk of breaking a bone, has been approved by the European Medicines Agency (EMA).
Romosuzumab – sold under the brand name EVENITY® – is a bone-building drug that not only increases bone formation but to a lesser extent reduces bone loss. However, it may not be suitable for people with a history of heart attacks or strokes.
The Food and Drug Administration (FDA) approved the medication in the US back in April after safety and efficacy data from two clinical trials, involving more than 11,000 women with post-menopausal osteoporosis, showed that it could lower the risk of a new spinal fracture by 73%.
Use of the medication in the UK was initially denied in June due to concerns about why the medicine appeared to increase the risk of heart and circulatory problems.
However, the EMA has now decided to give regulatory approval for romosozumab following an appeal, provided that its use is restricted to women with no history of heart attack and stroke.
The EMA said: “The Agency finally concluded that if restricted in this way, the benefits of Evenity would outweigh its risks in postmenopausal women with severe osteoporosis who are at a high risk of fracture. Additional measures and studies are foreseen to follow its use in practice and to ensure that the medicine is used correctly.”
Given that osteoporosis causes one in two women to experience a fracture in her lifetime, UK approval of the medicine is very positive, and means that healthcare professionals and patients will have more choice in clinically effective osteoporosis treatments.
Alison Doyle, our head of clinical practice and operations, says: “We welcome the approval of this highly effective drug. It is important to remember that, as with any medication, there are side effects that need to be considered and romosozumab may not be suitable for everyone. However, it is a highly effective drug that will benefit many people.
"It has taken 15 years of research to get to this point, and it’s been nine years since the last osteoporosis drug was approved. With no other new treatments on the horizon, this really is a positive step and provides improved patient choice.”
She adds: “Drugs aren’t the only solution though. We also need to better understand the causes of osteoporosis, which is why our Osteoporosis and Bone Research Academy is working with patients, research clinicians and academics in the field to advance our knowledge and ultimately find a cure for osteoporosis.”
The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use throughout the European Union. A decision by the EC is expected by the end of the year.