Eladynos

Eladynos is a medicine that contains the active substance abaloparatide. It was to be available as a solution for injection under the skin.

Eladynos was to be used to treat osteoporosis in women who have been through the menopause and who are at risk of bone fractures, a complication of osteoporosis.

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to fracture. In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall.

The active substance in Eladynos, abaloparatide, is similar to part of the human parathyroid hormone. It stimulates bone formation by acting on osteoblasts (bone-forming cells).

The company presented the results of one main study in women who had been through the menopause and who were at risk of fractures. Women received Eladynos or teriparatide (another medicine used to treat osteoporosis) or placebo (a dummy treatment) for 18 months. Measures of effectiveness were the number of new vertebral fractures and the number of non-vertebral fractures (including hip fractures, which can be serious and disabling).

The CHMP considered that the main study did not satisfactorily show that Eladynos is effective at preventing non-vertebral fractures in women who have been through the menopause.

The data from two of the study sites were not reliable and had to be excluded as the study had not been conducted in compliance with ‘good clinical practice’ (GCP) at those sites.

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.

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 Eladynos did not outweigh its risks and recommended that the medicine be refused marketing authorisation. The CHMP refusal was confirmed after re-examination.

The company informed the CHMP that there are no ongoing clinical trials with Eladynos in Europe.