Lux Biosciences, Isotechnika Pharma Inc. Receive Complete Response Letter from FDA for Voclosporin; FDA Requests Additional Information and Clinical Trial; Isotechnika Shares Dive 32.56% at 1:22PM EDT
A CRL is issued by the FDA when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form. The FDA has requested additional information and recommended that an additional clinical trial be conducted in order to consider a future approval of voclosporin for this indication.
"We will continue to work closely with the FDA to gain US regulatory approval for voclosporin, which we believe could offer an important new treatment option for patients with this serious disease," stated Dean Mitchell, President & Chief Executive Officer of Lux Biosciences. "Our confidence in the benefit/risk profile is based on the results of the LX211-01 trial which demonstrated clinically meaningful efficacy with tolerable side effects."
"Lux's Board of Directors is supportive of our starting the additional trial," continued Mr. Mitchell. "At the same time, the European Medicines Agency review of the Marketing Authorization Application for voclosporin remains on course for completion in the first quarter of 2011."
"Although we are faced with a delay, I am delighted and encouraged that the Board of Directors and Management of Lux are fully prepared to rapidly initiate recruitment of the additional clinical study required to complete the submission to the FDA," stated Dr. Robert Foster, President & CEO of Isotechnika Pharma."
More information on Isotechnika Pharma can be found at www.isotechnika.com or www.SEDAR.com.
We seek Safe Harbour.
For further information
Dr. Robert Foster, President & CEO, Isotechnika Pharma Inc., 780-487-1600 (247), 780-484-4105 (fax), rfoster@isotechnika.com Dr. Launa Aspeslet, Chief Operating Officer, Isotechnika Pharma Inc., 780-487-1600 (225), 780-484-4105 (fax), laspeslet@isotechnika.com