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FDA Ruling on Qualifying BMD as a Surrogate Endpoint for Osteoporosis Drugs is Expected Within 10 Months - Seite 2

The below is an excerpt from ABSMR March 25^th press release¹:

According to the Centers for Disease Control and Prevention, more than 53 million people in the United States alone have or are at a high-risk for osteoporosis, a bone disease that develops when bone mass decreases, leading to an increase in the risk of fractures. Fractures, particularly of the hip, are considered the most serious consequence of osteoporosis, which predominantly affects postmenopausal women and older men. Patients and their families collectively spend an estimated $52 billion annually in healthcare costs for osteoporosis-related bone breaks, an expense that is predicted to double in the next decades due to the increased aging of the US population.

“Preventing and treating osteoporosis-related fractures isn't just about strengthening bones; it's about enhancing quality of life and saving lives,” added ASBMR President Laura Calvi, MD. “Embracing BMD as a surrogate endpoint in clinical trials will revolutionize the journey of novel therapeutic agents to the clinic, reducing both time and costs, and ultimately it will  lead to improved treatment options for individuals with osteoporosis.”

About ASBMR-FNIH SABRE

The American Society for Bone and Mineral Research (ASBMR) is the leading professional, scientific and medical society established to bring together clinical and experimental scientists involved in the study of bone, mineral and musculoskeletal research.

Initiated in 2013, the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium Bone Quality Project assembled data from more than 150,000 participants across more than 50 clinical trials of anti-osteoporosis drugs. Analysis of these data by the project team indicated a strong association between the treatment-related increase in bone mineral density, as measured by dual-energy X-ray absorptiometry (DXA), and the observed reduction in fracture risk. These findings provide strong evidence that the change in bone mineral density could be used in future clinical trials to determine the effectiveness of osteoporosis drugs. Through a partnership with ASBMR, the FNIH extended and continues to support the original study, renamed SABRE, to seek FDA approval for the surrogate biomarker.