This sNDA includes the removal of a dosing recommendation, which limited Aloxi use to once per seven day interval, from the product's label. Data from several safety and efficacy trials that evaluated multiple day dosing of Aloxi were included in the sNDA.
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. Additioanlly, it is approved for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Multi-day chemotherapy regimens frequently used to treat certain lung, colon and testicular cancers, and leukemias, often present a significant challenge in preventing chemotherapy induced nausea and vomiting (CINV) due to the overlap of the acute and delayed phases of CINV.
The companies claim that the elimination of this dosing restriction from the Aloxi label removes a barrier to health care providers administering the drug more than once per week, which may be necessary when treating cancer with multi-day chemotherapy regimens.
“The Aloxi post-operative nausea and vomiting sNDA is under review with a PDUFA date of March 4, 2008 and pre-launch activities are underway,” said Eric Loukas, executive vice president and COO of MGI Pharma.