European Commission approves Aloxi for children

The European Commission has endorsed the Committee for Medicinal Products for Human Use’s (CHMP) Opinion recommending the approval of Aloxi (palonosetron HCl) from privately-held Swiss cancer specialist Helsinn Group.

Aloxi injection is recommended for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, in pediatric patients one month of age and older. This is the first European approval of a product for the prevention of acute chemotherapy-induced nausea and vomiting (CINV) in children aged one to six months. Since the childhood cancer incidence tends to be higher within the first three years of life, this approval offers an important therapeutic option to children, and especially young infants, undergoing cancer chemotherapy. This follows the US Food and Drug Administration approval of Aloxi for pediatric use in the USA last year.

Riccardo Braglia, Helsinn Group chief executive, said: “The European Commission's approval of Aloxi injection for the prevention of acute nausea and vomiting in children aged one month or more is an important validation of Helsinn’s position as a world-leading company in cancer supportive care and of its development expertise. This approval will give another treatment option for physicians when treating childhood cancer, in particular for the fragile infancy group.”