Aprepitant belongs to a class of agents known as NK1 receptor antagonists, which are often used in combination with 5-HT3 receptor antagonists for the prevention of CINV.
The NDA filing 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.
Heron Therapeutics drug development executive vice president Kimberly J. Manhard said: “The filing of the NDA for CINVANTI is an important milestone, bringing us one step closer to a new NK1 receptor antagonist treatment option for cancer patients suffering from the debilitating side effects of chemotherapy.
“We look forward to working closely with the FDA during the review of the NDA for CINVANTI in anticipation of FDA approval in late 2017.”
Heron Therapeutics chief executive officer Barry D. Quart, Pharm.D. said: “CINVANTI is based on the most widely used NK1 receptor antagonist, with almost 9 years of safety and efficacy experience.
“Since NK1 receptor antagonists are used in combination with 5-HT3 receptor antagonists, CINVANTI offers a strong strategic and operational fit with Heron’s existing commercial product, SUSTOL, our extended-release, injectable product that incorporates the 5-HT3 receptor antagonist granisetron and is also indicated for the prevention of CINV.”
CINVANTI is a proprietary intravenous formulation of aprepitant, a NK1 receptor antagonist for the prevention of CINV. NK1 receptor antagonists are typically used in combination with 5-HT3 receptor antagonists.
Currently, the only injectable NK1 receptor antagonist approved in the U.S. contains polysorbate 80, a surfactant, which may cause hypersensitivity reactions, infusion site reactions or other adverse reactions in some patients.
Heron’s formulation for CINVANTI does not contain polysorbate 80 and may have a lower incidence of certain types of adverse reactions than reported with the other commercially available injectable NK1 receptor antagonist.