US FDA approves Eisai’s Aloxi for children and extends exclusivity

29 May 2014

Japanese drug major Eisai (TYO: 4523) announced today that the antiemetic agent Aloxi (palonosetron HCI) has been approved in the USA for an additional indication.

The US Food and Drug Administration has approved the drug for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy, in children aged one month to 17 years.

Despite peak cancer incidence among children occurring within the first year of life, this is the first product for chemotherapy-induced nausea and vomiting (CINV) prevention approved in patients aged between one and six months after birth. Eisai’s US subsidiary Eisai Inc. markets this product based on having received exclusive marketing rights from Switzerland’s Helsinn Healthcare for the USA.

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