Genta withdraws NDA for Genasense
Genta has notified the U.S. Food and Drug Administration (FDA) of its decision to withdraw a New Drug Application (NDA) for Genasense (oblimersen sodium) Injection.
Genta has notified the U.S. Food and Drug Administration (FDA) of its decision to withdraw a New Drug Application (NDA) for Genasense (oblimersen sodium) Injection.
The NDA had been submitted in December 2003 for the use of Genasense plus dacarbazine for the treatment of patients with advanced melanoma. On May 3, 2004, an FDA Advisory Committee voted not to recommend Genasense for marketing approval. Under the Prescription Drug User Fee Act, the time for review of the NDA would have expired on June 8, 2004.
Coincident with the NDA withdrawal, Genta has requested a meeting with the FDA to review key issues and to identify next steps related to further development of Genasense in melanoma.
US law firm of Berger & Montague has announded that it is expanding the Class Period in the class action suit against Genta and certain of its principal officers and directors in the United States District Court for the District of New Jersey to include all persons or entities who purchased Genta securities between March 26, 2001 and May 3, 2004.
Plaintiff alleges that defendants violated the federal securities laws by issuing materially false and misleading statements throughout the Class Period that had the effect of artificially inflating the market price of the Company's securities. Specifically, plaintiff alleges that throughout the Class Period, defendants misrepresented the safety and efficacy of the Company's drug, Genasense, for the treatment of advanced melanoma, the most deadly form of skin cancer.
During the Class Period, defendants falsely represented to the investing public that Genasense did not appear to be associated with serious adverse reactions in the Phase III clinical trial. In fact, defendants knew that the use of Genasense was associated with increased toxicity and discontinuations due to adverse events, and that US Food and Drug Administration approval of the Genasense New Drug Application was unlikely because the increased toxicity and adverse events associated with the use of Genasense outweighed its marginal benefits.