Astellas receives US approval for tacrolimus

Astellas' tacrolimus extended-release capsule therapy for the prophylaxis of organ rejection in patients receiving a kidney transplant has been approved in the US.

The drug will be known as Astagraf XL in the US and is intended for use among patients with mycophenolate mofetil and corticosteroids, both with and without basiliximab induction.

Approval was granted by the US Food and Drug Administration based on positive data from international phase III trials involving more than 1,000 patients.

Tacrolimus extended-release capsules have been available for this indication under the name Advagraf in Europe since 2007, while it was also approved in Japan as Graceptor the following year.

Dr Sef Kurstjens, chief medical officer at Astellas Pharma, said: "The approval of Astagraf XL marks an important milestone in post-transplant care as it provides physicians with a new treatment option for kidney transplant recipients."

This comes after the company announced the UK launch of its EU-approved new prostate cancer therapy Xtandi earlier this month.