Eladynos

Eladynos received a marketing authorisation valid throughout the EU on 12 December 2022.

Eladynos is given once daily as an injection under the skin of the lower abdomen (belly). The maximum duration of treatment with Eladynos is 18 months. Patients or their carers can inject Eladynos themselves once they have been trained to do so.

During treatment with Eladynos, the patient should take calcium and vitamin D supplements if they are not getting enough from their diet.

The medicine can only be obtained with a prescription. For more information about Eladynos, see the package leaflet or contact your doctor or pharmacist.

In a main study involving 2,070 patients, Eladynos was more effective than placebo (a dummy treatment) in reducing fractures in the spine in women with osteoporosis who have been through menopause.

After 18 months, 0.5% of those treated with Eladynos had a new spinal fracture compared with 4.2% in the group who received placebo.

The most common side effects with Eladynos (which may affect more than 1 in 10 people) are hypercalciuria (high calcium levels in the urine) and dizziness. Other common side effects (which may affect up to 1 in 10 people) are back pain, nausea, headache, joint pain, high blood pressure, reactions at the injection site, and palpitations (a forceful heartbeat that may be rapid or irregular). For the full list of side effects of Eladynos, see the package leaflet.

Eladynos must not be used in women who are hypersensitive (allergic) to abaloparatide or any of the other ingredients, pregnant or breastfeeding women, women who are able to have children and women with hypercalcaemia (high calcium levels in the blood), severely reduced kidney function or unexplained high levels of alkaline phosphatase (an enzyme). Eladynos must also not be used in patients at risk for osteosarcoma (a type of bone cancer) or in patients who have bone cancer or cancer that has spread to the bones.

For the full list of restrictions, see the package leaflet.

There is a need for new safe and effective medicines for preventing fractures in women who have been through menopause and have osteoporosis. The main study showed that Eladynos reduces the risk of spinal fractures in these patients. The results also suggest that it may reduce the risk of non-spinal fractures.

Regarding safety, the side effects of Eladynos were mostly mild to moderate. Although Eladynos can increase the heart rate after injection, there is no evidence that it causes major heart problems. As a precaution, doctors should assess the risks before starting treatment and should monitor the heart function of patients with cardiovascular disease (affecting the heart and blood circulation).

The European Medicines Agency decided that Eladynos’ benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eladynos have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Eladynos are continuously monitored. Suspected side effects reported with Eladynos are carefully evaluated and any necessary action taken to protect patients.

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).

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.

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

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.