Envarsus tacrolimus regulatory update

FDA approved an NDA from Veloxis for Envarsus tacrolimus XR for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus XR. The company expects to launch the product next quarter. Envarsus is delivered using Veloxis’ MeltDose technology.

Last month, the U.S. District Court for the District of Columbia ruled that FDA was correct in granting tentative approval of Envarsus XR 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. ...