FDA Approves Combination Therapy from Eisai and HelsinnBy
The US Food and Drug Administration has approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy. Akynzeo is distributed and marketed by Eisai Inc. of Woodcliff Lake, New Jersey, under license from Lugano, Switzerland-based Helsinn Healthcare S.A.
Akynzeo is a fixed combination capsule comprised of two drugs. Oral palonosetron, approved in 2008, prevents nausea and vomiting during the acute phase (within the first 24 hours) after the start of cancer chemotherapy. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of cancer chemotherapy.
Based on a licensing agreement between Eisai and Helsinn signed in June 2010, Akynzeo will be co-promoted in the US by the two companies' respective US subsidiaries: Eisai Inc. and Helsinn Therapeutics U.S. Inc. Eisai Inc. will book sales of the product in