FDA approves sNDA of Cinvanti for nausea and vomiting from chemotherapy.- Heron Therapeutics

Heron Therapeutics announced that the FDA has approved Heron's supplemental New Drug Application (sNDA) for Cinvanti (aprepitant) injectable emulsion for intravenous (IV) use. The sNDA requested FDA approval to expand the recommended dosage to include the 130 mg single-dose regimen for patients receiving MEC.

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 HEC and MEC. Results from two pivotal, randomized, 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. In February 2019, the FDA approved Heron's sNDA to expand the administration of Cinvanti beyond the already approved administration method (a 30-minute IV infusion) to include a 2-minute IV injection (also referred to as an IV push). This 2-minute IV push for Cinvanti was approved based on a third study demonstrating bioequivalence and a comparable safety profile to Cinvanti given as a 30-minute IV infusion.