LuveniqTreatment for Uveitis
Complete Response Letter for Luveniq NDA
Lux Biosciences Receives Complete Response Letter from FDA for Luveniq
JERSEY CITY, N.J.--(BUSINESS WIRE)--Aug 4, 2010 - Lux Biosciences, Inc. today announced that the U.S. Food and Drug Administration's Center of Drug Evaluation and Research has issued a Complete Response letter regarding the New Drug Application (NDA) for Luveniq (oral voclosporin) for the treatment of non-infectious uveitis.
FDA issues a Complete Response letter when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form. Lux Biosciences and its partner Isotechnika Pharma are evaluating the Complete Response letter, in which the FDA has indicated that it regards the data from one of the two pivotal studies submitted in the NDA as positive. Lux Biosciences plans to conduct an additional pivotal trial of Luveniq, expected to begin before the end of 2010.
"We continue to work with FDA to address their outstanding questions regarding the safety and efficacy of Luveniq, and the Lux Biosciences' board of directors is supportive of our starting the additional trial," said Dean Mitchell, Lux Biosciences' President and Chief Executive Officer. "At the same time, the European Medicines Agency review of the Marketing Authorization Application for Luveniq remains on course for completion in the first quarter of 2011."
Lux Biosciences announced submission of both the NDA and MAA for Luveniq on February 3, 2010.
About Lux Biosciences
Lux Biosciences, Inc. is a privately held biotechnology company focused on the treatment of ophthalmic diseases. Lux Biosciences has exclusive worldwide rights to voclosporin for all ophthalmic indications and is cooperating with the team at Isotechnika Pharma who discovered the molecule. For more information on Lux Biosciences, please visit the company's website at http://www.luxbio.com.
Lux Biosciences cautionary statement regarding forward-looking statements
This press release may contain forward-looking statements, including Lux Biosciences' belief as to the medical and commercial potential of its product candidates, Lux Biosciences' plans to pursue business and regulatory strategy, and Lux Biosciences' expectations regarding actions and decisions solely within the control and purview of other parties. These forward-looking statements involve important known and unknown risks and uncertainties, which could cause actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the exercise of discretion by regulatory agencies and other parties, the availability to Lux Biosciences of funds and resources to pursue research and development projects, the performance of activities and generation of scientific data by parties other than Lux Biosciences, the ability of Lux Biosciences to economically manufacture and commercialize its products once approved, acceptance by the medical community of Lux Biosciences' products once approved and the availability of alternative therapeutic agents, approval for reimbursement by third-party payors of Lux Biosciences' products once approved, the success and timely completion of clinical trials and other scientific studies, the ability of Lux Biosciences and its licensors to defend its and their patents from infringement by third parties, and the risk that such patents may be subsequently shown to be invalid or that the practice of such patents may infringe the patents of others. Further, Lux Biosciences disclaims any undertaking to issue further press releases or otherwise advice about changes to these beliefs, plans and expectations.
Contact: Kureczka/Martin Associates
Joan Kureczka, +1-415-821-2413
Posted: August 2010
- FDA cancels advisory committee meeting for voclosporin - Priority review of Lux Biosciences ' NDA continues - June 23, 2010
- FDA Advisory Committee to Review Lux Biosciences' Uveitis Candidate Luveniq - May 11, 2010
- Lux Biosciences' Luveniq Receives FDA Priority Review - March 30, 2010
- Lux Biosciences Files for Luveniq Approval in US and Europe for Noninfectious Uveitis - February 4, 2010