Saniona (OMX: SANION), a clinical-stage biopharmaceutical company, today announces that its partner, Productos Medix S.A de S.V (Medix), has not received approval from the Mexican regulatory agency (Cofepris) for tesofensine for the treatment of obesity. Instead, Medix is entering a dialogue with the agency regarding the path forward as it appears that the decision by Cofepris has not been based on the full data package as submitted by Medix.
The application is based on a Phase 3 program involving 372 patients conducted by Medix. The study confirmed compelling efficacy, with patients achieving an average weight loss of about ten percent in 24 weeks, and more than half of the patients experiencing a weight loss of more than ten percent. In general, tesofensine was very well tolerated, and a clinical safety database containing approximately 1600 patients provided a robust safety dataset.