The European Medicines Agency ( EMA ) has recommended the refusal of the marketing authorisation for Evenity, a medicine intended for the treatment of osteoporosis.
Evenity was developed as a medicine for the treatment of osteoporosis in women who have been through the menopause and men at increased risk of bone fractures.
Evenity contains the active substance Romosozumab and was to be available as an injection to be given under the skin once a month for a year.
Romosozumab, is a monoclonal antibody that attaches to a specific target in the body called sclerostin.
Sclerostin is a natural substance that plays an important role in regulating formation and breakdown of bone. By attaching to sclerostin and blocking its action, Romosozumab increases the formation of new bone tissue, and reduces the breakdown of existing bone. This helps strengthen bones and reduce the risk of fractures.
To support its application, the company ( UCB Pharma ) presented data on the quality, safety and effectiveness of Evenity, including two main studies involving over 11,000 postmenopausal women with osteoporosis and one main study involving 252 men with osteoporosis.
In one of these studies, involving women considered at high risk of fracture, the medicine was compared with another osteoporosis medicine, Alendronate, and in the other two studies it was compared with placebo.
The main measure of effectiveness in all the studies was the number of new fractures that developed in the bones of the spine ( vertebrae ).
EMA was concerned because the results suggested that patients given Evenity had an increased risk of serious effects on the heart or circulatory system, such as myocardial infarctions or strokes.
In addition, when all the data were looked at together, there were more deaths in patients aged over 75 years given the medicine.
As it was unclear why the medicine appeared to increase the risk of heart and circulatory problems, and there was no obvious group of patients in whom the risk of these was lower, measures to reduce the risk could not readily be put in place.
With respect to its beneficial effects, Evenity was effective in reducing the risk of fracture in patients with severe osteoporosis, although the benefit was not so convincing in patients with less severe disease.
Under the circumstances, the EMA’s opinion was that the benefits of Evenity did not outweigh its risks and it recommended refusing marketing authorisation. ( Xagena )
Source: European Medicines Agency ( EMA ), 2019