Veloxis Pharmaceuticals A/S and Chiesi Farmaceutici S.p.A. announced that the European Commission (EC) has granted marketing authorization for Envarsus for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU).

 

Key points:

 

• The EMA marketing authorization is based on review of the favorable results of the Envarsus Phase 3 3001 study in stable kidney transplant patients and 3002 study in de novo kidney transplant recipients as well as data from an extensive Phase 1 and 2 clinical program, which included both kidney and liver transplant patients. 
• Studies 3001 and 3002 demonstrated that Envarsus dosed once-daily was not inferior to the current leading transplant drug, Prograf (tacrolimus), dosed twice-daily. The Phase 1 pharmacokinetic and Phase 2 efficacy data that was submitted in the MAA enabled extrapolation into the broader populations of both kidney and liver transplant recipients. 
• The marketing authorization includes both the de novo transplant and “switch” settings, as well as for treatment of rejection episodes resistant to treatment with other immunosuppressive products in adult patients. 
• There are approximately 20,000 kidney transplants performed each year in the EU and approximately 7,000 liver transplants. 
• Chiesi Farmaceutici S.p.A., through an exclusive license and distribution agreement with Veloxis, will hold the Marketing Authorization and commercialize Envarsus in the European Union. 
• Veloxis’ New Drug Application (NDA) for Envarsus XR for the prevention of organ rejection in kidney transplant patients is under regulatory review by the U.S. FDA and has a PDUFA action date of October 30, 2014. Veloxis does not expect to receive the additional liver indication in the U.S. 
• Envarsus XR received Orphan Drug Designation by the U.S. FDA for prophylaxis of organ rejection in patients receiving allogeneic kidney transplants. 

 

Date: July 28, 2014

Source: Veloxis Pharmaceuticals