Aeterna Zentaris files demand with FDA for Fast Monitor designation for AEZS-130 Aeterna Zentaris Inc. The request is portion of the Company’s New Drug Program strategy for AEZS-130 to advance the product towards regulatory approval as efficiently as possible. The FDA’s Fast Monitor program was created, among other things, to facilitate the development and expedite the overview of new drugs that demonstrate the potential to handle unmet medical needs read all article . According to its guidance on Fast Monitor applications, the FDA responds within 60 days of receipt of such requests.
Aeterna’s AEZS-108 final Phase 2 results in endometrial malignancy to be presented at ESGO 2011 Aeterna Zentaris Inc. The trial was executed by the German AGO Study Group and research centers in Bulgaria. AEZS-108, a targeted cytotoxic peptide conjugate, is usually in Phase 1/2 applications in prostate and bladder malignancy currently, and has successfully completed Stage 2 trials in endometrial and ovarian cancer.