Entera Bio Welcomes FDA Qualification of Bone Density as Regulatory Endpoint for New Drugs

Entera Bio congratulates the FNIH-ASBMR-SABRE team following the Food and Drug Administration broad qualification of total hip bone mineral density as a validated regulatory endpoint for novel drugs in development for post-menopausal women at risk for osteoporotic fracture. "Since mid-2022, Entera has been steadfast in our public advocacy and support of the SABRE initiative and the FDA's plan to implement this significant regulatory reform," said Miranda Toledano, CEO. "Over 200 million women globally are estimated to have osteoporosis and remain vastly undertreated, yet no new drug for osteoporosis has been approved by FDA since 2019. Innovation has stalled largely due to the size, duration, cost and ethical constraints associated with fracture endpoint studies. In the last three years, we have been privileged to forge meaningful ties and build an ecosystem of patients, clinicians, and change agents committed to addressing this significantly underserved area," continued Toledano. "In July 2025, Entera was the first company to receive FDA alignment that a single Phase 3 study with total hip BMD as primary endpoint would support an NDA for EB613. The Agency's position paper and broad qualification may further simplify our path forward."