On October 26, 2017 OPKO Health, Inc. (NASDAQ:OPK) reported that its licensee, TESARO, Inc. (Nasdaq:TSRO), received U.S. Food and Drug Administration (FDA) approval for VARUBI (rolapitant) IV 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 (Press release, Opko Health, OCT 26, 2017, View Source [SID1234521224]). Delayed nausea and vomiting can occur anytime between 25 and 120 hours following chemotherapy, and is often extremely debilitating.
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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 IV. 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 IV in November 2017.
“We are especially pleased that our partner, TESARO, has received FDA approval for VARUBI IV. This is particularly important as IV treatments for chemotherapy induced nausea and vomiting account for 90% of the market. We look forward to TESARO’s continued success in commercializing the VARUBI product line,” said Philip Frost, M.D., Chairman and Chief Executive Officer of OPKO Health.
About VARUBI
VARUBI is a highly selective and competitive antagonist of human substance P/neurokinin 1 (NK-1) receptors, which play an important role in the delayed phase of chemotherapy induced nausea and vomiting (CINV). With a long plasma half-life of approximately seven days, a single dose of VARUBI, as part of an antiemetic regimen, significantly improved complete response (CR) rates in the delayed phase of CINV. Results from three Phase 3 trials of VARUBI oral tablets demonstrated a significant reduction in episodes of vomiting or use of rescue medication during the 25- to 120-hour period following administration of highly emetogenic and moderately emetogenic chemotherapy regimens. In addition, patients who received VARUBI reported experiencing less nausea that interfered with normal daily life and fewer episodes of vomiting or retching over multiple cycles of chemotherapy. Results from a bioequivalence trial demonstrated comparability of the IV and oral formulations of VARUBI.
VARUBI is available by prescription only. Please see full prescribing information, including additional important safety information, available at www.varubirx.com.