Heron Announces FDA Approval of sNDA to Expand CINVANTI® Label for IV Push

Heron Therapeutics announced the U.S. Food and Drug Administration (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 administration of CINVANTI beyond the already approved administration method (a 30-minute IV infusion) to include a 2-minute IV injection.

CINVANTI is the first and only polysorbate 80-free, IV formulation of an NK1 receptor antagonist (RA) indicated for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce CINV in both the acute phase (0 – 24 hours after chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy). 

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 (HEC) and moderately emetogenic cancer chemotherapy (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. 

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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.

"CINVANTI, delivering the efficacy of aprepitant, but without polysorbate 80, has been an important addition for the prevention of CINV. Notably, data now show that the 2-minute IV push has comparable safety to the 30-minute IV infusion. This approval will enable physicians to leverage the operational advantages of this method of administration and will contribute to a reduction in total patient time spent in the infusion suite," said Rudolph M. Navari, M.D., Ph.D., University of Alabama, Birmingham School of Medicine, Division of Hematology Oncology.

"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," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "Administration of CINVANTI by 2-minute IV push is an important advantage for our customers compared to EMEND IV, which requires reconstitution and an IV bag for infusion."

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin, and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). CINVANTI is an IV formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist (RA). CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0 – 24 hours after chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy). CINVANTI is the only IV formulation of an NK1 RA indicated for the prevention of acute and delayed nausea and vomiting associated with HEC and nausea and vomiting associated with MEC that is free of polysorbate 80 or any other synthetic surfactant. The FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute infusion or a 2-minute injection.

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