Corixa Files Request for Formal Dispute Resolution With FDA on BEXXAR
In its Appeal, Company Requests Appearance at ODAC Meeting
SEATTLE & PHILADELPHIA--(BW HealthWire)--May 31, 2002--Corixa Corp. (Nasdaq: CRXA - News) and
GlaxoSmithKline (NYSE: GSK - News) today announced that Corixa has filed a request for formal dispute resolution,
appealing the position articulated by U.S. Food and Drug Administration (FDA) on the approval status of BEXXAR® in
its complete review letter dated March 12, 2002.
Corixa also requested the opportunity to present data on the safety and efficacy of BEXXAR in the treatment of relapsed
or refractory low-grade and transformed-low grade non-Hodgkin's lymphoma (NHL) to a meeting of the Oncologic
Drugs Advisory Committee (ODAC).
"This request initiates the dispute resolution process provided under the Food and Drug Administration Act (FDAMA),"
stated Steven Gillis, Ph.D., chairman and chief executive officer at Corixa. "The filing also summarizes our strong belief that
BEXXAR should be approved on the basis of the number of durable responses demonstrated across multiple clinical
trials."
Under FDA procedures, requests for formal dispute resolution are sent to the appropriate dispute resolution project
manager at the Agency. Appeals are then reviewed by the appropriate Center for Biologics Evaluation and Research
official as established under the Center's chain of command. A written response from the Agency should be provided
within 45 days of receipt of the request for dispute resolution. If additional information is required for the official to make a
decision, that time period may be extended.
Although no new information may be submitted as a part of a request for dispute resolution, if an appeal is granted, Corixa
could then provide the FDA with additional data in support of the contention that BEXXAR meets an unmet medical need
that has not been observed with currently approved therapies. If an appeal is granted, the timing of an ODAC meeting
would be dependent upon the receipt and review of additional information submitted in connection with the BLA.
However, a presentation before ODAC this year remains a possibility, subject to approval of the appeal.
Further information regarding the procedures for dispute resolution is available in the February 2000 FDA Guidance for
Industry document, "Formal Dispute Resolution - Appeals Above the Division Level" and can be accessed at
fda.gov <snip> |
