A Randomized, Double-blind, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women With Severe Osteoporosis and at Risk of Fracture
Phase of Trial: Phase III
Latest Information Update: 21 Jul 2017
At a glance
- Drugs Abaloparatide (Primary) ; Teriparatide
- Indications Fracture; Postmenopausal osteoporosis
- Focus Registrational; Therapeutic Use
- Acronyms ACTIVE
- Sponsors Radius Health Inc.
- 21 Jul 2017 According to a Radius Health media release, the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), issued a second Day-180 List of Outstanding Issues and requested additional data analyses related to the safety and efficacy of abaloparatide-SC in the process of their ongoing regulatory review. Radius expects the CHMP to issue an opinion regarding the MAA for abaloparatide-SC prior to the end of 2017.
- 28 Apr 2017 According to a Radius Health media release, FDA has approved TYMLOS (abaloparatide) injection for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy based on results of this and ACTIVExtend trials.
- 10 Mar 2017 The US FDA announced in March 2017 that the Prescription Drug User Fee Act (PDUFA) date for abaloparatide-SC has been extended to June 30, 2017, according to a Radius Health media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History