Veloxis and Chiesi receive approval from European Commission on anti-organ rejection drug
Denmark-based Veloxis Pharmaceuticals (OMX: VELO) and Italian company Chiesi Farmaceutici have said that the European Commission has granted marketing authorization for their drug Envarsus (once-daily tacrolimus, formerly LCP-Tacro), which works to prevent organ rejection in adult kidney and liver transplant patients.
This approval is based on the review of favorable results coming from the Envarsus Phase III 3001 study in stable kidney transplant patients and 3002 study in de novo kidney transplant recipients as well as data from Phase I and II clinical programs which included kidney and liver transplants.
The studies showed that a once-daily dose of Envarsus was not inferior to the current leading drug, Astellas’ Prograf, dosed twice-daily.
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