JERSEY CITY, N.J.--(BUSINESS WIRE)--Lux Biosciences, Inc. today announced that the U.S. Food and Drug Administration has accepted the filing of the company’s New Drug Application for Luveniq™ (oral voclosporin) and has granted the application priority review.
A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes FDA to review a new drug application is reduced; the goal for completing a Priority Review is six months.
“We are very pleased that Luveniq is now under active regulatory consideration in both the United States and Europe, and that the FDA is providing an expedited review in recognition of the potential of this experimental drug and high need for new therapies,” said Eddy Anglade, M.D., Lux Biosciences’ Chief Medical Officer.
Luveniq™ (oral voclosporin) is the oral form of a next-generation calcineurin inhibitor, voclosporin. Like other molecules of this class, the compound reversibly inhibits immunocompetent lymphocytes, particularly T-lymphocytes, and it also inhibits lymphokine production and release. 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.
About Lux Biosciences
Lux Biosciences, Inc. is a privately held biotechnology company focused on the treatment of ophthalmic diseases. 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.
+1 415 821 2413
+1 415 690 0210 Mobile