Zelos Therapeutics Reaches Agreement With The FDA And EMEA For A Registration Study Of ZT-031 For...

Zelos Therapeutics, Inc. has reached agreements with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for a Phase 3 registration study of ZT-031 for the treatment of severe osteoporosis. Following the special clinical protocol assessment (SPA) process with the FDA and a formal scientific advice meeting with the Committee for Human Medicinal Products of the EMEA, Zelos Therapeutics has received regulatory approval for the design, conduct and analysis of a pivotal Phase 3 clinical study. The trial, if successful, would form the primary basis for an efficacy claim to support applications for marketing authorization of ZT-031 in the United States and Europe. "The FDA's and EMEA's formal agreement with our clinical study design is a major accomplishment for Zelos Therapeutics and a significant... [read full story]