LupkynisTreatment for Lupus Nephritis
FDA Advisory Committee to Review Luveniq NDA
FDA Advisory Committee to Review Lux Biosciences' Uveitis Candidate Luveniq
JERSEY CITY, N.J.--(BUSINESS WIRE)--May 11, 2010 - Lux Biosciences, Inc. today announced that the Dermatology and Ophthalmology Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review its New Drug Application (NDA) for Luveniq (oral voclosporin) for the treatment of non-infectious uveitis involving the intermediate or posterior segments of the eye on June 28, 2010.
Lux Biosciences submitted its NDA on February 4, 2010 seeking approval to market Luveniq in the United States; on March 30, 2010, the FDA accepted the NDA filing for review and granted the NDA priority review. The target PDUFA date for the FDA to complete its review of the Luveniq NDA is August 3, 2010. The FDA is not bound by the Advisory Committee's recommendation, but may take its advice into consideration when evaluating the NDA for Luveniq.
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 Bioscience's belief as to the medical and commercial potential of its product candidates, Lux Bioscience's plans to pursue business and regulatory strategy, and Lux Bioscience's 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: May 2010
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- Lux Biosciences Receives Complete Response Letter from FDA for Luveniq - August 10, 2010
- FDA cancels advisory committee meeting for voclosporin - Priority review of Lux Biosciences ' NDA continues - June 23, 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
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