Heron’s Civanti supplemental NDA accepted by FDA

Heron Therapeutics said Wednesday that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Cinvanti (aprepitant) injectable emulsion, for intravenous (IV) use.

The sNDA 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 bioequivalence of Cinvanti to Emend IV (fosaprepitant), supporting its efficacy for the prevention of acute and delayed CINV after highly emetogenic cancer chemotherapy (HEC) and moderately emetogenic cancer chemotherapy (MEC).

Heron said that the new method of administration for Cinvanti was approved based on a third study demonstrating bioequivalence and a comparable safety profile for Cinvanti given as a 30-minute IV infusion and as a 2-minute IV injection, also referred to as an IV push.

Rudolph M. Navari from University of Alabama, Birmingham School of Medicine, Division of Hematology Oncology explained that Cinvani has been an important addition for the prevention of CINV, delivering the efficacy of aprepitant, but without polysorbate 80.

“Notably, data now show that the 2-minute IV push has comparable safety to the 30-minute IV infusion,” he said.

Barry Quart, President and Chief Executive Officer of Heron, “We are pleased to have strengthened our CINV franchise with today’s label expansion for Cinvanti , as we now have the only NK₁ RA that offers the benefits and flexibility of an IV push method of administration.”