FDA Refuses To Approve Tesaro's Intravenous Formulation Of Rolapitant

(RTTNews) - The U.S. Food and Drug Administration has refused to approve Tesaro Inc.'s (TSRO) intravenous formulation of Rolapitant, developed for the prevention of chemotherapy-induced nausea and vomiting.

While no concerns have been raised related to efficacy or safety profile, the regulatory agency has sought additional information regarding the in vitro method utilized to demonstrate comparability of Rolapitant IV produced at the two proposed commercial manufacturers of the drug product.

An oral formulation of Rolapitant was approved by the FDA under brand name Varubi on September 1st, 2015, and has been available in the U.S. since last November. Sales of Varubi totaled $4.41 million in the first nine months of 2016. Tesaro obtained an exclusive, royalty bearing, sublicensable worldwide license, to research, develop, manufacture, market and sell Rolapitant from Opko Health Inc. (OPK) in December 2010.

TSRO closed Wednesday's trading at $145.90, down 0.91%.