FDA OKs Cinvanti for chemo-induced nausea and vomiting

The US Food and Drug Administration approved Cinvanti (aprepitant) injectable emulsion, for intravenous infusion, from US specialty biotech firm Heron Therapeutics (Nasdaq: HRTX), for the prevention of acute and delayed nausea and vomiting associated with chemotherapy in adult patients.

The approval will allow the company to boost its position in the global chemotherapy-induced nausea and vomiting (CINV) market, which is estimated to grow at a compound annual growth rate (CAGR) of 5.41% through 2021 to around $2 billion. Heron’s currently marketed CINV therapy Sustol (granisetron) was approved by the FDA in August 2016.

Cinvanti is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, 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). With this approval, Heron now is the only company with approved injectable therapies that address the two primary mechanisms of CINV: Sustol, a serotonin-3 (5-HT3) receptor antagonist, and Cinvanti, an NK1 receptor antagonist.