FDA Calendar Updates: Eisai, SuperGen

Written by Mike Havrilla

Wednesday, 08 July 2009 00:00

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 249 entries as of 7/8/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/8/09, Eisai (OTC:ESALY) (TYO:4523) announced that the FDA has accepted for review the company's supplemental new drug application (sNDA) for an alternative five-day dosing regimen for Dacogen (decitabine for injection) to treat patients with myelodysplastic syndromes (MDS). MDS is a potentially life-threatening group of bone marrow diseases that limit the production of functional blood cells. Currently, Dacogen is approved for use as a three-day regimen, administered at a dose of 15 mg/m2 via continuous IV infusion over three hours repeated every eight hours for three consecutive days per cycle. The cycle is repeated every six weeks. The alternative five-day dosing regimen of Dacogen submitted to the FDA is a single daily dose with a significantly reduced administration time.

SuperGen (NASDAQ:SUPG) receives royalties on Dacogen sales based on a 2004 license agreement entered into with MGI Pharma (which was acquired by Eisai in January 2008) for the exclusive rights to the development, manufacture, commercialization, and distribution of Dacogen. The PDUFA action date for the sNDA is 3/8/10 for a possible FDA decision as part of a 10-month, standard review.

Disclosure: No positions.

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