FDA Accepts sNDA For Eisai’s Dacogen

FDA has accepted for review, Eisai’ supplemental new drug application (sNDA) for an alternative five-day dosing regimen for Dacogen (decitabine for injection). It is intended to treat patients with myelodysplastic syndromes (MDS).

The company said that the alternative five-day dosing regimen of Dacogen submitted to the FDA, is a single daily dose with a significantly reduced administration time. If approved, patients with MDS may experience increased convenience with the new dosing regimen, said the company.

Cynthia Schwalm, President of Eisai, said: We’re pleased that the FDA has agreed to review our application for the alternative dosing regimen and we look forward to working with the agency throughout the review process”.

This application is one part of a full complement of clinical development programs we have committed for Dacogen and is a vital part of our human health care mission of increasing patient benefits and fulfilling unmet medical needs, she added.