
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
Filed Under: Drug Discovery