The FDA has accepted the filing of Lux Biosciences? new drug application for oral voclosporin (Luveniq) and has granted the application priority review, according to the company.
Jersey City, NJ
-The FDA has accepted the filing of Lux Biosciences’ new drug application for oral voclosporin (Luveniq) and has granted the application priority review, according to the company. The company is anticipating completion of the review in about 6 months.
“We are very pleased that [oral voclosporin] 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, MD, Lux Biosciences’ chief medical officer.
Oral voclosporin is the oral form of the 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.
The application is for use in non-infectious uveitis involving the intermediate or posterior segments of the eye.
Lux Biosciences has exclusive worldwide rights to voclosporin for all ophthalmic indications and is cooperating with the team at Isotechnika Pharma that discovered the molecule.