FDA approves Varubi i.v .for the prevention of delayed nausea/ vomiting associated with emetogenic cancer chemotherapy. Tesaro.
OPKO Health, Inc. announces that its licensee, Tesaro Inc. received FDA approval for Varubi (rolapitant) i.v. in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Delayed nausea and vomiting can occur anytime between 25 and 120 hours following chemotherapy, and is often extremely debilitating.
Tesaro licensed exclusive rights for the development, manufacture, commercialization, and distribution of Varubi (rolapitant) from OPKO Health in December 2010 . Tesaro previously launched an oral version of Varubi in November 2015 . OPKO Health will receive tiered double-digit royalties on sales of VARUBI i.v. In addition, OPKO Health is eligible to receive additional commercial milestone payments of up to $85 million upon achievement of certain sales thresholds. Tesaro is expected to launch VARUBI i.v. in November 2017.
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