CINVANTI is our proprietary formulation of aprepitant that has the potential to be the first polysorbate 80-free, intravenous formulation of this widely used pharmaceutical agent. Aprepitant (and its prodrug, fosaprepitant) is the most widely used neurokinin-1 (NK1) receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting (CINV). NK1 receptor antagonists are typically used in combination with 5-HT3 receptor antagonists for the prevention of CINV.
At present, fosaprepitant, the aprepitant prodrug, is the only injectable NK1 receptor antagonist approved in the US Fosaprepitant contains polysorbate 80, which may cause allergic reactions, including the potential to cause severe anaphylaxis, and infusion site reactions.1 In a review of cancer drugs containing polysorbate 80, hypersensitivity reactions were linked to at least 23 deaths in spite of the fact that all 23 patients had received premedication to prevent hypersensitivity reactions.2
CINVANTI does not contain polysorbate 80 and may have a lower incidence of certain types of adverse reactions than reported with the commercially available injectable NK1 receptor antagonist.
In January 2017, we filed an NDA for CINVANTI using the 505(b)(2) regulatory pathway which includes data demonstrating the bioequivalence of CINVANTI to EMEND IV® (fosaprepitant), supporting its efficacy for the prevention of both acute and delayed CINV with both moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC). Results also showed CINVANTI was better tolerated than EMEND IV, with significantly fewer adverse events reported with CINVANTI. The US Food and Drug Administration (FDA) set a Prescription Drug User Fee Act (PDUFA) goal date of November 12, 2017, for a decision on the company's NDA for CINVANTI.