Federal Court Rules in FDA’s Favor in Tacrolimus NDAs Lawsuit

A federal judge says the FDA did not unlawfully decide to delay final approval of Veloxis Pharmaceuticals’ extended-release immunosuppression drug Envarsus.

In October 2014, the FDA granted Veloxis tentative approval of Envarsus XR (tacrolimus) for the prevention of organ rejection in de novo kidney transplant patients, but told Veloxis it must wait to launch until a patent on Astellas’ Astagraf XL (tacrolimus) expires in July 2016 — due to three-year exclusivity.

Veloxis sued the FDA in December, claiming that the delay was unjust because it didn’t rely on any data in the Astagraf NDA. Veloxis’ clinical program was based on the FDA’s recognition of the differences between Envarsus XR and Astellas’ immediate-release capsule Prograf (tacrolimus), as well as Astagraf XL.

While the term “relied upon” is not defined in the FD&C Act, the statutory provision is clear as to how three-year exclusivity operates, writes Judge Reggie Walton of the U.S. District Court for the District of Columbia in an opinion released this week.

Veloxis argued that Astagraf XL is not entitled to exclusivity because the law prohibits granting exclusivity to drugs that contain antibiotics approved prior to 1997, unless the application for approval was submitted after October 2008.

But Walton sided with the FDA, pointing out that Astagraf XL was properly awarded three-year exclusivity because its original NDA was withdrawn in 2009 and a new one was submitted in 2012. The FD&C Act is silent as to withdrawal and resubmission of an old antibiotic NDA that was pending on or before October 2008, but the FDA’s interpretation of the statute to allow three-year exclusivity is reasonable, he says.

Veloxis has not said whether it will appeal the decision in Veloxis Pharmaceuticals, Inc. v. United States Food and Drug Administration, et al. Attorney Kurt Karst, with Hyman Phelps & McNamara, says the drugmaker could forgo an appeal and accept the FDA’s previously offered approval of an indication outside the scope of exclusivity granted for Astagraf XL, such as for prophylaxis of organ rejection for use in conversion patients. — Jonathon Shacat