ALOXI injection receives FDA approval for prevention of nausea.

‘We are pleased with the Agency's decision to approve ALOXI in the pediatric setting, giving children with cancers another option to assist in preventing acute chemotherapy-induced nausea and vomiting,’ said Yuji Matsue, Chairman and CEO, Eisai Inc.’ Related StoriesResearch shows link between lack of RB protein and long-term survival rates in lung malignancy patientsChemotherapy-induced nausea and vomiting most common distressing symptoms in most cancer patientsMD Anderson study reveals why chemotherapy medications not effective for most pancreatic cancer patients’Preventing nausea and vomiting induced by chemotherapy remains an unmet need in children, despite available therapies,’ stated Riccardo Braglia, CEO, Helsinn Group.’ In response to a written demand from the FDA, Helsinn carried out four pediatric scientific trials with ALOXI.15 mg/kg given thirty minutes prior to chemotherapy followed by infusions four and eight hours after the first dose of ondansetron.4 % of patients who received ALOXI 20 mcg/kg versus 58.6 % of those who received the ondansetron regimen.The mean overnight glucose level was considerably lower with the closed-loop program than with the control system , as was the time spent above the target range . The proportion of time that the sensor glucose level indicated a blood glucose level below 70 mg per deciliter was less than 4 percent, and the proportion of the time that the sensor glucose level indicated a blood sugar level below 50 mg per deciliter was less than 1 percent; these values were very similar during the two study periods. Glucose variability, as measured by the typical deviation of the over night sensor glucose level and the coefficient of variation between nights, was considerably less with the closed-loop program than with the control system.