Gentium Withdraws New Drug Application for Defibrotide
Gentium S.p.A. (Nasdaq: GENT) today announced that it has voluntarily withdrawn the New Drug Application (NDA) for Defibrotide following recent correspondence from the United States Food and Drug Administration (FDA) identifying numerous "Refuse to File" issues regarding the Company's NDA submission.
In their initial review, the FDA raised concerns regarding the completeness of the datasets for both the treatment and prevention studies. The FDA requested that the Company conduct additional quality reviews of the original datasets and databases. The FDA also requested additional details regarding the conduct and monitoring of the trials by the independent review committee.
"Given the number of issues raised by the FDA and the short deadline we have to address such issues, we felt that it was appropriate to voluntarily withdraw our NDA submission for Defibrotide," stated Dr. Khalid Islam, Chairman and Chief Executive Officer of Gentium S.p.A. Dr. Islam added, "It is our plan to address these concerns as quickly as possible and to work closely with the FDA to provide an updated and complete NDA."
