The National Institute for Health and Care Excellence (NICE) has approved Theramex's Eladynos (abaloparatide) for routine NHS use, potentially offering a new treatment option for approximately 14,000 postmenopausal women in England at increased risk of osteoporotic fractures. However, widespread access to the drug faces significant challenges due to insufficient diagnostic capacity within the NHS.
Clinical Significance and Mechanism of Action
Eladynos functions as an analogue of parathyroid hormone-related protein (PTHrP) and belongs to the class of anabolic agents. Like its counterparts romosozumab and teriparatide, it actively builds bone mass rather than merely slowing bone deterioration, as seen with older bisphosphonate treatments. The medication is administered via daily self-injection, distinguishing it from romosozumab's monthly healthcare provider-administered dosing schedule.
Treatment Landscape and Unmet Need
The approval marks a significant milestone as only the second osteoporosis treatment to become available to UK patients in the past 15 years. Current treatment options have been limited to UCB's Evenity (romosozumab), Eli Lilly's Forsteo (teriparatide), and generic bisphosphonates such as alendronic acid. Eladynos provides an important alternative for patients who either cannot tolerate or do not respond to existing therapies.
Disease Burden and Patient Impact
Osteoporosis affects approximately 3.8 million people in the UK, with fractures representing the fourth leading cause of disability and premature death. Professor Jonathan Benger, NICE's chief medical officer and deputy chief executive, emphasized the condition's devastating impact: "The independent committee heard from patients about how debilitating osteoporosis can be and how it impacts all aspects of day-to-day life, such as not going out for a walk because they are fearful of falling and having a fracture."
Access Challenges and Healthcare Infrastructure
Despite the approval, the Royal Osteoporosis Society (ROS) has raised serious concerns about access to treatment. A critical shortage in Fracture Liaison Services (FLS) across NHS Trusts means two-thirds of osteoporosis patients currently miss out on treatment. Craig Jones, ROS' chief executive, highlighted this disparity: "Sadly, it's no good having new medication options if half of NHS Trusts don't have diagnostic services to put people onto them."
Future Outlook
The newly appointed Health and Social Care Secretary Wes Streeting has pledged to establish universal FLS coverage in NHS Trusts by 2030. The ROS has urged immediate action on this commitment to address the current "chronic postcode lottery" in diagnostic services and ensure equitable access to new treatments like Eladynos.
