MGI Pharma & Helsinn announce filing of NDA for palonosetron
MINNEAPOLIS, MINN. and LUGANO, SWITZERLAND, November. 26, 2002 -- MGI Pharma an oncology-focused pharmaceutical company, and its partner Helsinn Healthcare SA, a privately-owned Swiss pharmaceutical group, announced that the FDA has accepted their New Drug Application (NDA) for filing. The NDA was submitted on September 27, 2002 for approval to market palonosetron, an agent for the prevention of chemotherapy-induced nausea and vomiting (CINV).
The NDA included clinical data from successfully completed Phase 3 clinical trials of palonosetron in both moderately- and highly-emetogenic CINV. The application's acceptance for review represents the FDA's determination that the NDA is sufficiently complete to permit a substantive review. Filing of the application by the FDA does not represent any opinion regarding the safety, efficacy or approvability of the product. Under the PDUFA III (Prescription Drug User Fee Act), the FDA's goal is to review and act on the NDA within 10 months of receipt.
Palonosetron is a potent, highly selective 5-HT3 receptor antagonist with a strong receptor-binding affinity and an extended plasma half-life, in development for the prevention of CINV, which, if not prevented, is estimated to afflict 85 percent of cancer patients undergoing chemotherapy. Clinical studies to date have demonstrated that palonosetron was well tolerated and adverse events were similar to currently marketed 5-HT3 antagonists, with the most common being mild to moderate headache and constipation.
In April 2002, MGI and Helsinn announced the achievement of the primary endpoint in the pivotal Phase 3 trials of palonosetron, based on preliminary analysis of the data. In June, positive results were reported from one of the three pivotal trials in the Phase 3 program of palonosetron at the Multinational Association of Supportive Care in Cancer (MASCC) International Symposium, and the companies expect to present additional Phase 3 data at future oncology meetings.
Source: MGI Pharma and Helsinn Healthcare
Posted: November 2002