MGI Pharma, INC, a biopharmaceutical company focused in oncology and acute care, and its partner Helsinn Healthcare SA, a privately owned Swiss pharmaceutical group, announced that the supplemental New Drug Application (sNDA) for Aloxi (palonosetron hydrochloride) injection for the prevention of post-operative nausea and vomiting was accepted for filing by the United States Food and Drug Administration (FDA).
Aloxi is approved by the FDA for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
The sNDA for Aloxi Injection was submitted to the FDA on May 7, 2007. The acceptance for review of the NDA represents the FDA's determination that the application is sufficiently complete to permit a substantive review of the data. The filing of the application by the FDA does not represent any opinion regarding the safety, efficacy or approvability of Aloxi Injection. Under PDUFA (Prescription Drug User Fee Act) III, the FDA's goal is to review and act on the NDA by March 4, 2008.
The sNDA included data from two randomised, multi-centre, phase III trials conducted to evaluate the safety and efficacy of three doses of Aloxi compared to placebo for the prevention of PONV. In these two trials, a total of 1,219 patients undergoing elective outpatient abdominal or gynaecological laparoscopic surgery or elective inpatient gynaecological or breast surgery were randomised to receive one of three single intravenous doses of Aloxi or placebo prior to administration of anaesthesia. Data were collected to examine the effectiveness and safety of Aloxi during the time course of patient risk for nausea and vomiting, regardless of inpatient or outpatient site of postoperative care on the day of surgery and for two more days (0-72 hrs). Both clinical trials successfully met the primary efficacy endpoint of complete response, defined as no emesis or use of rescue medication, for the 0-24 hour time period and the key secondary efficacy endpoint of complete response for the entire 0-72 hour time period following surgery, for the proposed dose of 0.075 mg.