The US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Aloxi (palonosetron hydrochloride) filed jointly by MGI Pharma, Inc and its partner Helsinn Healthcare SA.
Aloxi was 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 Capsules was submitted to the FDA on October 24, 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 Capsules for oral administration. Under PDUFA (Prescription Drug User Fee Act) III, the FDA's goal is to review and act on the NDA by August 22, 2008.
Aloxi is approved by the US 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. Aloxi is the first and only 5-HT(3) receptor antagonist to be indicated for the prevention of delayed CINV caused by moderately emetogenic cancer chemotherapy. The most common adverse reactions related to Aloxi were headache (9 per cent) and constipation (5 per cent). Aloxi is contraindicated in patients known to have hypersensitivity to the drug or any of its components.
Helsinn is a privately owned pharmaceutical group with headquarters in Switzerland. Helsinn's core business is the licensing of pharmaceuticals in therapeutic areas (oncology, cancer supportive care, pain and inflammation, gastrointestinal). The company's business strategy is to in-license early-stage new chemical entities and to complete their development from the performance of pre-clinical/clinical studies and CMC development to the attainment of market approvals in strategic markets (US and Europe).
MGI Pharma, Inc. is a biopharmaceutical company focused in oncology and acute care that acquires, researches, develops, and commercializes proprietary products that address the unmet needs of patients.
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