NICE recommends Eladynos®▼ (abaloparatide) for treating osteoporosis in postmenopausal women

• Eladynos^® has been recommended by the National Institute for Health and Care Excellence (NICE) for the treatment of postmenopausal women with osteoporosis at increased risk of fracture in England and Wales, in draft guidance

• The risk of a second fracture within 1 year of the first is 5x greater than having a fracture at all therefore, a wider range of treatments to prevent the first fracture are needed¹

• Theramex is committed to supporting women at every life stage

Embargoed. London, 21 June 2024: Theramex has announced that the NICE has recommended Eladynos^® for the treatment of osteoporosis in postmenopausal women at increased risk of fracture, through the NHS.²

Osteoporosis is a progressive skeletal disorder characterised by low bone mass and deterioration of the structure of bone tissue, resulting in increased bone fragility and susceptibility to fracture.³ In England and Wales, it is estimated that more than 2 million women have osteoporosis.⁴

Osteoporotic fragility fractures occur most commonly in the hip, spine, and wrist.³ This can cause substantial pain and severe disability, often leading to a reduced quality of life.³ Around 30% of deaths after hip or vertebral fractures can be attributed to the fracture event, and approximately 50% of fracture-related deaths in women are due to hip fractures.⁵

Now available to >4,000 eligible postmenopausal women in England and Wales, Eladynos^® can be injected at home, once a day, allowing for treatment flexibility.⁶

Professor Nicholas Harvey, Director of the Medical Research Council Lifecourse Epidemiology Centre said, "Worldwide fractures related to osteoporosis affect 1 in 3 women and 1 in 5 men over the age of 50 years,⁷ and within the UK alone, cost £4.5 billion per year.⁸ These are devastating, potentially life-changing or indeed life-limiting events, but are preventable. It is therefore very welcome news for both clinicians and patients – in this instance postmenopausal women – that our treatment options, which improve bone density and reduce fracture risk, have been expanded through this recent NICE approval.”

Eugene McCloskey, Professor in Adult Bone Diseases, University of Sheffield said, “For postmenopausal women, osteoporosis can have a detrimental effect on their everyday standard of living and quality of life. Sadly, over 80% of very-high risk patients do not receive any osteoporosis treatment.⁹ Therefore, NICE’s approval of Eladynos^® is a significant and necessary next step in widening access to treatment options for women across England and Wales, helping everyone to live a higher quality of life.”

Tina Backhouse, UK General Manager, Theramex said, “With women at a five times greater risk of osteoporosis than men,¹⁰ NICE’s recommendation of Eladynos^® is a step forward in ensuring that women have flexible access to the care they need through a diversity of treatment options. Not only will we work with NICE and the NHS, but we will also continue conversations with Government to ensure that they deliver on their promise to broaden access to Fracture Liaison Services across England and Wales, ending the postcode lottery for osteoporosis care.”

Craig Jones, CEO, Royal Osteoporosis Society said, “With around 90,000 people¹¹ in England and Wales currently missing out on vital osteoporosis treatment, wider accessibility to medicines like Eladynos^® is important in helping people live their full lives for longer.”

“That’s why we’re so pleased that both the Conservative and Labour parties have accepted our campaign request to ensure that each NHS Trust in England and Wales has a Fracture Liaison Service to better support diagnosis, prevention and treatment of osteoporosis. With services like this in place, we could prevent 74,000 fractures over five years in England alone¹¹ and so, we urge the Government to move quickly in setting up these services.”

The NICE appraisal is based on evidence from the ACTIVE study, an 18-month treatment and 1-year follow-up in postmenopausal women aged 50–86 (N=2,070). It was a randomised, multicentre, double-blind, placebo- and open-label active comparator-controlled (teriparatide) clinical study.² The primary endpoint was met and demonstrated that subcutaneous injection of Eladynos^® significantly reduced the risk of new vertebral fractures by 88% vs placebo (incidence of new vertebral fracture 0.51% vs 4.17% respectively, p<0.0001).²

In the ACTIVE trial, the most commonly reported adverse drug reactions with Eladynos^® included hypercalciuria (15.6%), dizziness (11.1%), back pain (8.6%), nausea (8.5%), headache (8.5%), arthralgia (8.4%), hypertension (6.8%), injection site reaction (6.2%) and palpitations (5.6%).²

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information.