FDA has qualified Total Hip BMD as a validated surrogate endpoint for new osteoporosis drugs, boosting Entera’s regulatory strategy for EB613. Entera aims to democratize anabolic treatment for osteoporosis globally. The company applauds the FDA’s decision, which may simplify drug development and approval processes. Osteoporosis affects over 200 million women worldwide, with limited treatment options. EB613, an oral anabolic tablet, shows promise in improving bone health, meeting key endpoints in clinical trials. Osteoporosis is a significant public health concern, leading to millions of fractures annually and billions in medical costs. Entera Bio is at the forefront of developing innovative oral peptide therapies for various medical needs.

Read more at GlobeNewswire: Entera Bio Congratulates the FNIH-ASBMR-SABRE Team on FDA’s