US subsidiary of the company Eisai Inc. is marketing the product based on having received exclusive marketing rights from Helsinn Healthcare for the US.
The company said that despite peak cancer incidence among children occurring within the first year of birth, ALOXI is the first product for chemotherapy-induced nausea and vomiting (CINV) prevention approved in patients aged between 1 and 6 months after birth.
The company’s US subsidiary Eisai Inc. markets the product based on having received exclusive marketing rights from Helsinn Healthcare for the US.
The approval was based on a randomized, double-blind, non-inferiority pivotal trial comparing ALOXI with ondansetron in pediatric patients.
The trial’s primary endpoint of Complete Response, defined as no vomiting, no retching and no antiemesis rescue medication required within the first 24 hours after chemotherapy, was achieved in 59.4% of patients who received ALOXI (20mcg/kg, single-dose IV) versus 58.6% of patients who received the ondansetron regimen.
The company said that treatment-emergent adverse events (TEAEs) were comparable across both arms, with the most frequently reported TEAE in the ALOXI group being headaches.
Additionally, the clinical trial data has met the FDA’s Written Request requirements for pediatric exclusivity, resulting in an additional six months of US market exclusivity for the drug, which will now expire on 13 October 2015.