In a significant development for osteoporosis treatment in the UK, the National Institute for Health and Care Excellence (NICE) has approved abaloparatide, a highly effective anabolic therapy, for patients at high risk of fracture.
Known commercially as Tymlos, Eladynos, or Ostavaro, abaloparatide has been gaining traction in the global osteoporosis market due to its strong efficacy and growing physician familiarity.
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This approval marks an important milestone, providing UK patients with a new option that specifically targets parathyroid hormone receptors to stimulate osteoblast activity and enhance bone formation.
Already launched in the US in 2017 and approved in several European countries in 2022, abaloparatide’s introduction into the UK market is expected to significantly impact the treatment landscape for severe osteoporosis.
Osteoporosis is the most prevalent metabolic bone disorder worldwide and a leading cause of fragility fractures.
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This systemic skeletal condition is characterised by a reduction in bone mass and the degradation of bone structure, which elevates the risk of fractures, particularly in areas such as the spine, hip, distal forearm, and proximal humerus.
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By GlobalDataThese fractures contribute significantly to patient morbidity, often requiring extended recovery periods and comprehensive care.
Despite its serious impact, osteoporosis frequently remains undetected until a fracture occurs, earning it the title of a ‘silent disease’.
Osteoporosis usually develops gradually over several years and goes unnoticed until a fracture brings it to medical attention.
More than two-thirds of vertebral fractures occur without pain, making early detection challenging.
Common symptoms include back pain from fractured vertebrae, which can result in visible deformity or reduced mobility.
Additionally, the condition can lead to a hunched posture, known as kyphosis, as vertebral fractures cause the spine to collapse and bend forward, further impairing an individual’s physical function and quality of life.
As the second anabolic therapy to enter the market, abaloparatide offers a critical alternative to antiresorptive agents, which have traditionally dominated osteoporosis treatment.
Its solid efficacy profile has made it particularly valuable for patients with severe osteoporosis, where treatment adherence is crucial for patient outcomes.
However, despite its clinical strengths, abaloparatide’s once-daily subcutaneous injection presents a challenge for elderly patients, who may find it difficult to maintain a daily injection routine.
Furthermore, its high price compared to more affordable osteoporosis drugs such as bisphosphonates, has constrained its patient share in some markets.
The UK approval of abaloparatide is expected to boost its market presence, particularly given its established use in the US and Japan.
This international track record provides UK prescribers with confidence in its effectiveness and safety, potentially accelerating its adoption.
However, the therapy must contend with increasing competition from other anabolic agents such as Eli Lilly’s Forteo and the rise of biosimilars, which could impact its market share.
Additionally, the growing popularity of newer treatments such as Amgen’s Evenity poses a further challenge.
Despite these competitive pressures, abaloparatide is poised to play a significant role in the UK osteoporosis market.
With projected sales across the seven major markets (US, France, Germany, Italy, Spain, UK, and Japan) expected to reach $551.9m by 2033, the drug is set to remain a key player in the osteoporosis treatment landscape.
The NICE approval highlights its therapeutic value and emphasises the ongoing need for innovative treatments to address severe osteoporosis in high-risk patients.
The NICE approval of abaloparatide could significantly improve osteoporosis patient outcomes by providing a highly effective treatment option for those at severe risk of fractures.
This advancement offers enhanced bone health and reduced fracture rates, and has the potential to alleviate the burden on National Health Service osteoporosis management by reducing long-term care needs and associated healthcare costs.
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