Appeal for development of new osteoporosis drug treatment rejected by European Medicines Agency

27 Jul 2018

An appeal for the development of a potential new osteoporosis drug treatment has been rejected by the European Medicines Agency, due to safety concerns about the medicine's effect on the heart and a lack of evidence that it was effective in preventing non-vertebral fractures in women who have been through the menopause.

Abaloparatide was being developed by pharmaceutical company Radius International Ltd., to treat postmenopausal women with osteoporosis who are at risk of bone fractures.

But in March, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) refused to give the drug the go-ahead in Europe.

Following an appeal, the CHMP has now announced that they will uphold their original findings.

“From a safety point of view, the CHMP was concerned about the medicine’s effects on the heart, such as increases in heart rate and palpitations," the Agency said in a statement.

"Because most post-menopausal women are at an increased risk of heart problems, the CHMP could not identify a group of patients in whom the benefits would outweigh the risks. Therefore, at that point in time, the Committee was of the opinion that the benefits of abaloparatide did not outweigh its risks and recommended that the medicine be refused marketing authorisation. The CHMP refusal was confirmed after re-examination," they continued.

Fizz Thompson, Clinical Director at the National Osteoporosis Society, said that while it was disappointing a potentially promising new treatment for osteoporosis would not now see the light of day and give patients further choice, patient safety always had to be the primary concern.

“The National Osteoporosis Society will continue to support research in the field of osteoporosis to build a future where there is a range of safe and effective treatments available for people affected by the condition.”

Professor Neil Gittoes, Honorary Professor of Endocrinoloy and Head of the Centre for Endocrinology, Diabetes and Metabolism at the University of Birmingham, said the EMA’s decision was “disappointing”.

“It is disappointing that abaloparatide, a bone forming (anabolic) drug, will not be available for prescribing. A wider choice of therapies for those with osteoporosis allows us greater scope to deal with different clinical situations. We are keen to see appropriate greater use of bone anabolic drugs as they offer us the most robust means to reduce fracture risk and somewhat reverse the process of osteoporosis."

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