Liver, kidney transplantation drug receives authorization in Europe

The European Commission has granted Envarsus marketing authorization for treating adult kidney and liver transplant patients, according to a media release.

The authorization allows the immunosuppressant tacrolimus (Envarsus, Veloxis Pharmaceuticals/Chiesi) for the prevention of organ rejection in kidney and liver recipients in the European Union (EU).

“This approval enables our partner, Chiesi, to offer a novel alternative therapy to kidney and liver transplant patients in the European Union,” William Polvino, chief executive officer of Veloxis, said in the release. “It further validates our clinical development plan and our underlying MeltDose technology. We now look forward to the initial launch of Envarsus in EU markets starting late this year.”

The drug received marketing authorization after favorable results in multiple clinical trials, according to the release. In two phase 3 trials, Envarsus taken once daily was not inferior to twice-daily tacrolimus (Prograf, Astellas Pharma), the current leading transplant drug, when taken by kidney transplant recipients, the release said. Favorable results also were reported after phase 1 and 2 trials involving kidney and liver transplant recipients.

“As marketing authorization holder, we are fully committed to execute both the commercialization and roll out of an important program of further clinical studies for this innovative product,” Paolo Chiesi, vice president of Chiesi Farmaceutici, said in the release. “We believe Envarsus will be a valuable therapeutic for a broad population of transplant recipients.”

The FDA granted Veloxis an orphan drug designation for Envarsus to help prevent organ rejection in kidney transplant recipients, and Veloxis has a new drug application pending. It does not anticipate receiving the additional liver indication in the US, the release said.