Cinvanti NDA Submitted for CINV Prevention
Heron Therapeutics announced the submission of the New Drug Application (NDA) for Cinvanti (HTX-019) to the Food and Drug Administration (FDA) for the prevention of chemotherapy-induced nausea and vomiting (CINV).
The Cinvanti NDA submission was based on data which demonstrates its bioequivalence to Emend injection (fosaprepitant; Merck), supporting its efficacy for the prevention of both acute and delayed CINV with both moderately and highly emetogenic chemotherapy. In addition, data also showed that Cinvanti was better tolerated and associated with significantly fewer adverse events compared to Emend.
Cinvanti is the first polysorbate 80-free, intravenous formulation of aprepitant, a NK1 receptor antagonist. The lack of polysorbate 80 in its formulation reduces the incidence of adverse events such as hypersensitivity and infusion site reactions.
For more information call (844) 437-6611 or visit Herontx.com.