Veloxis Pharmaceuticals A/S commented on an order issued by the U.S. District Court for the District of Columbia in connection with the action it filed on December 16 against the U.S. Food and Drug Administration (FDA). Veloxis is seeking an order requiring the FDA to grant final approval to Envarsus(® )XR.
“We are pleased that the court recognizes our need for an expedited resolution of this matter, and has indicated that it will set a briefing timetable that will result in the matter being fully briefed in a timely fashion. We had previously requested and anticipated that approximately two months would be required to achieve a full briefing under the strategy Veloxis had proposed, and we are pleased to see the court order reflecting consistency with this timeline.”
Envarsus XR is a once-daily extended-release tablet indicated for prophylaxis of organ rejection in kidney transplant patients. The FDA determined that the period of statutory exclusivity granted to another extended-release tacrolimus product, Astagraf XL®, blocks Envarsus XR from being sold in the United States until that exclusivity period expires in July 2016, as previously announced by the company on October 31, 2014.
Veloxis is arguing that the FDA’s action is contrary to the requirements of the controlling statute, its regulations and longstanding agency precedent. It is asking the court to immediately grant Envarsus XR approval for sale in the United States.