The positive opinion of the CHMP is for both kidney and liver transplant recipients and 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.
The CHMP’s decision will be referred to the European Commission (EC) and if approved, the company will receive marketing authorisation for Envarsus in all member states of the EU.
The EC is expected to make a final decision for Envarsus within three months of the opinion.
The opinion is based on review of the favourable results of the Envarsus Phase III 3001 trial in stable kidney transplant patients and 3002 trial in de novo kidney transplant recipients as well as data from an extensive Phase I and II clinical programme, which included both kidney and liver transplant patients.
Both studies 3001 and 3002 showed that Envarsus dosed once-daily was not inferior to the current leading transplant drug, Prograf (tacrolimus), dosed twice-daily.
The company said that Phase I pharmacokinetic and Phase II efficacy data that was submitted in the MAA allowed extrapolation into the broader populations of both kidney and liver transplant recipients.
The FDA has accepted for review the company’s new drug application (NDA) for Envarsus for the prevention of organ rejection in kidney transplant patients and has set an action date of 30 October 2014 to respond to the submission.