Regulators in the USA have given the green light to Astellas Pharma's new organ rejection drug Astagraf XL.

The US Food and Drug Administration has approved Astagraf XL, an extended-release version of the Japanese drugmaker's off-patent Prograf (tacrolimus), its immunosuppressant for organ rejection in patients receiving a kidney transplant. The thumbs-up is for the once-daily oral drug to be used with a regimen that includes treatment with  with mycophenolate mofetil  and corticosteroids, with or without basiliximab induction.

Sef Kurstjens, chief medical officer at Astellas' US unit, said that "each transplant recipient is different and requires a personalised treatment approach". He added that the approval of Astagraf XL "marks an important milestone in post-transplant care as it provides physicians with a new treatment option".

Astellas has been selling once-daily tacrolimus as Advagraf in the European Union since 2007 and in Japan as Graceptor since 2008. The US approval is based on two Phase III studies which enrolled nearly 1,100 patients.