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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jul 2018

At a glance

  • Drugs Abaloparatide (Primary) ; Teriparatide
  • Indications Fracture; Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ACTIVE
  • Sponsors Radius Health Inc.
  • Most Recent Events

    • 24 Jul 2018 According to a Radius Health media release, after an oral explanation following a re-examination procedure, CHMP has communicated a negative trend vote for the Company's marketing authorization application (MAA) for abaloparatide-SC for the treatment of osteoporosis in postmenopausal women at increased risk for fracture.
    • 10 May 2018 According to a Radius Health media release,in April 2018, the company has submitted a request for re-examination of the CHMP's opinion.
    • 22 Mar 2018 According to a Radius Health media release, Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has communicated a negative trend vote on the benefit-risk balance for the Company's marketing authorization application (MAA) for abaloparatide-SC and CHMP adopt a negative opinion on the MAA on March 22, 2018.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top