Veloxis Pharmaceuticals transplant news
The U.S. District Court for the District of Columbia ruled that FDA was correct in granting tentative approval of immunosuppressant Envarsus tacrolimus XR from Veloxis to prevent organ rejection in kidney patients. The biotech filed the suit last December and was seeking full approval. Veloxis said the decision will delay full approval of Envarsus for use in de novo kidney transplant recipients until expiration of the exclusivity period of Astagraf XL tacrolimus from Astellas Pharma Inc. (Tokyo:4503, Tokyo, Japan.). Astagraf XL’s exclusivity is set to expire on July 19, 2016, or in January 2017 if Astellas receives a pediatric exclusivity extension. Veloxis said it submitted a class 1 labeling change to FDA seeking to allow patients who wish to convert from twice-daily tacrolimus to once-daily Envarsus tacrolimus XR. The company plans to launch the product with the new label in 4Q15, after an expected two-month labeling review timeline (see BioCentury, Dec. 22, 2014). ...