Pegozafermin - 89bio
Alternative Names: BIO-89-100; TEV 47948Latest Information Update: 22 Jan 2025
At a glance
- Originator Teva Pharmaceutical Industries
- Developer 89bio
- Class Antihyperlipidaemics; Antineoplastics; Fibroblast growth factors; Hepatoprotectants; Polyethylene glycols; Recombinant proteins
- Mechanism of Action Fibroblast growth factor 21 agonists
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Phase III Hypertriglyceridaemia; Non-alcoholic steatohepatitis
- Phase I/II Non-alcoholic fatty liver disease
- Preclinical Liver cancer
Most Recent Events
- 13 Jan 2025 89bio plans to files BLA with US FDA and MAA application with EMA for Hypertriglyceridemia
- 13 Jan 2025 89bio receives regulatory feedback from the US FDA and the European Medicines Agency (EMA) for pegozafermin on clinical as well as Chemistry, Manufacturing, and Controls (CMC) requirements for marketing authorization filings for Hypertriglyceridemia
- 13 Jan 2025 89bio completes enrolment in its phase-III ENTRUS Trial for Hypertriglyceridemia in USA, Argentina, Austria, Belgium, Bulgaria, Canada, Chile, Czech Republic, France, Georgia, Germany, Hungary, India, Italy, Latvia, Poland, Puerto Rico, Spain, Mexico and United Kingdom (SC)(NCT05852431)