Posted by Michael Wonder on 27 Feb 2019
Heron announces FDA approval of supplemental new drug application to expand Cinvanti label for IV push
26 February 2019 - Heron Therapeutics today announced that the U.S. FDA has approved Heron's supplemental new drug application for Cinvanti (aprepitant) injectable emulsion, for intravenous use.
The application requested FDA approval to expand the administration of Cinvanti beyond the already approved administration method (a 30 minute IV infusion) to include a 2 minute IV injection.
Cinvanti was initially approved based on data demonstrating the bioequivalence of CINVANTI to Emend IV (fosaprepitant), supporting its efficacy for the prevention of acute and delayed CINV following highly emetogenic cancer chemotherapy and moderately emetogenic cancer chemotherapy. Results from two pivotal, randomised, cross-over, bioequivalence studies of Cinvanti and Emend IV showed subjects receiving Cinvanti reported fewer adverse events than those receiving Emend IV, including substantially fewer infusion-site reactions.
