NICE Endorses Theramex’s Eladynos for Post-Menopausal Osteoporosis

Theramex's medication Eladynos (abaloparatide) is set to become available to menopausal women with osteoporosis in England within three months, following positive guidance from The National Institute for Health and Care Excellence (NICE). Marketed as Tymlos in the US by Radius Health, the drug aims to enhance bone density by stimulating the cells responsible for new bone formation, thus reducing the risk of fractures. Eladynos is administered via an injection using a pre-filled pen that can be self-administered at home once a day.

Theramex, a women’s health company, acquired the rights to Eladynos through an exclusive licensing agreement with Radius Health in March 2023. This deal allows Theramex to market the drug in the European Economic Area, the UK, Australia, and Brazil. The US Food and Drug Administration (FDA) approved Eladynos in April 2017 for postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 for men with a similar condition.

Menopause can lead to an accelerated loss of bone density due to a reduction in oestrogen levels, increasing the risk of osteoporosis. Traditional treatments for postmenopausal osteoporosis with a very high risk of fracture include UCB and Amgen’s Evenity (romosozumab) and Eli Lilly’s Forsteo (teriparatide). Evenity functions by inhibiting sclerostin to promote bone formation while reducing bone resorption. This drug had been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2020 and received a recommendation from NICE in April 2022 after initial cost concerns were addressed. Evenity generated $1.16 million in 2023, according to Amgen’s financial reports. However, some patients discontinue Evenity due to side effects such as osteonecrosis.

Forsteo operates similarly to Eladynos but acts through a different mechanism. It serves as a synthetic form of parathyroid hormone (PTH), stimulating bone formation by activating osteoblasts. Eladynos, on the other hand, is a synthetic peptide and a PTH-related peptide analogue that offers a different binding profile and potentially superior efficacy based on certain studies.

NICE has estimated that Eladynos could benefit more than 14,000 people in England. According to data from GlobalData, the osteoporosis market is projected to generate $17.9 billion across major markets including the US, UK, France, Germany, Spain, Italy, and Japan by 2033.

In the announcement, NICE’s chief medical officer Jonathan Benger emphasized the importance of access to therapies that improve quality of life while offering value to taxpayers. He noted that abaloparatide had been found to be clinically and cost-effective in reducing fracture risk, thus providing patients with more independence and an enhanced quality of life.