The New Drug Application (NDA) for Dacogen (decitabine) for injection was accepted for filing by the United States Food and Drug Administration (FDA), SuperGen, Inc. and MGI Pharma, Inc. have jointly announced here.

The NDA for Dacogen injection was submitted to the FDA on November 1, 2004. The acceptance for review of the NDA represents the FDA's determination that the application is sufficiently complete to permit a substantive review. The filing of the application by the FDA does not represent any opinion regarding the safety, efficacy or approvability of Dacogen injection. Under PDUFA (Prescription Drug User Fee Act) III, the FDA's goal is to review and act on the NDA by September 1, 2005. During October 2004 the Marketing Authorization Application (MAA) for Dacogen injection was submitted and is currently under review by the European Medicines Agency (EMEA), SuperGen said in a release.

The NDA included clinical data from one phase 3 clinical trial of Dacogen injection in MDS patients in addition to two phase 2 studies. The co-primary endpoints of the phase 3 study were response rate and time to AML transformation or death. The phase 3 trial achieved the co-primary endpoint of overall response rate. Patients in the Dacogen arm had a response rate of 17 per cent as determined by intent to treat (ITT) analysis, compared to a 0 per cent response rate for patients who received supportive care (p<0.001).

"This NDA filing represents the achievement of another key regulatory milestone for both MGI Pharma and SuperGen in our quest for marketing approval of Dacogen injection," Lonnie Moulder, president and chief executive officer of MGI Pharma said adding, "We look forward to initiating a phase 3 study of Dacogen injection in AML patients in early 2005,"

"We are very pleased that the Dacogen NDA has been accepted for review," said Dr. James Manuso, president and chief executive officer of SuperGen. "We believe that Dacogen injection will become an important treatment option for hematologic cancer patients," Dr Manuso added.

Dacogen injection is an investigational drug that belongs to a class of drugs called DNA methyltransferase inhibitors. In clinical trials, Dacogen injection has been shown to have a broad spectrum of activity in several haematological malignancies as well as solid tumours.

MDS is a cancer of the bone marrow that is often fatal. Some cases of MDS progress to leukaemia.

Meantime, SuperGen has informed that it had withdrawn its New Drug Application (NDA) for Orathecin (rubitecan) Capsules based on feedback indicating that the current data package would not be sufficient to gain approval for Orathecin at this time in the United States.

Orathecin is SuperGen's investigational drug for the treatment of pancreatic cancer patients who have failed at least one prior chemotherapy regimen.

SuperGen's decision to withdraw the filing was based on discussions with both the FDA and consultants helping the company dialog with the Agency regarding the Orathecin NDA, the company said.

Dr. James Manuso, chairman, president and CEO of SuperGen, stated, "Based on the feedback we received, we decided it was best for the long-term development of Orathecin to withdraw the application. After we review the FDA's complete findings, we will determine the most appropriate course of action for Orathecin in the US."

SuperGen originally submitted the NDA for Orathecin on January 26, 2004 with a target Prescription Drug User Fee Act (PDUFA) date of November 26, 2004. At the request of the FDA, the company recently submitted additional clinical data from a trial of Orathecin as a first-line treatment for pancreatic cancer as well as new analyses of data from the pivotal study in 2nd and 3rd line patients. The FDA classified these data as a Major Amendment, which triggered an extension of the review period by 90 days. The revised target PDUFA date was February 26, 2005.

Orathecin (rubitecan) Capsules, an orally active camptothecin, is a topoisomerase I inhibitor.