Helsinn Group announces European approval of ALOXI (palonosetron HCl) injection for paediatric use

The European approval of ALOXI^® for paediatric use follows the FDA approval in May 2014 of ALOXI^® for paediatric use in the US

Helsinn Group, the Swiss Group focused on building quality cancer care, today announces that the European Commission has endorsed the Committee for Medicinal Products for Human Use's (CHMP) Opinion recommending the approval of ALOXI^® (palonosetron HCl) injection 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 paediatric 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 3 years of life, this approval offers an important therapeutic option to children, and especially young infants, undergoing cancer chemotherapy.

Since its implementation, the European Paediatric Regulation has substantially increased the availability in Europe of high quality, ethically-researched medicines for use in children.

CINV is among the most common side effects following therapy in patients with cancer. In clinical trials in paediatric patients, CINV frequency varied from 35 to 80 percent depending on the age of the patient, the site of tumour and the type of chemotherapy given. Helsinn has conducted four paediatric clinical trials with ALOXI^®. The approval of the paediatric indication is based on a randomized, double-blind, non-inferiority pivotal trial comparing single-dose intravenous (IV) ALOXI^® 20 mcg/kg given 30 minutes prior to chemotherapy to a standard of care IV ondansetron regimen of 0.15 mg/kg given 30 minutes prior to chemotherapy followed by ondansetron infusions four and eight hours after the first dose. Within the first 24 hours after chemotherapy, Complete Response, defined as no vomiting, no retching and no antiemetic rescue medication, was achieved in 59.4 percent of patients who received ALOXI^® 20 mcg/kg and in 58.6 percent of those who received the ondansetron regimen. Therefore the study met its primary endpoint.

Treatment-emergent adverse events (TEAEs) were comparable across both treatments, with headache being the most frequent event in the palonosetron group. Although paediatric patients were administered a higher dose per kg than adults to prevent CINV, palonosetron safety profile was consistent with its established profile in adults.

Riccardo Braglia, CEO of Helsinn Group, 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."