This article is more than 5 years old. Information may no longer be current.

Astellas reports FDA approval of anti-rejection drug

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Astellas Pharma US Inc. announced Friday that the U.S. Food and Drug Administration has approved Astagraf XL, a once-daily anti-rejection drug for patients receiving a kidney transplant.

The drug is used with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction. "Each transplant recipient is different and requires a personalized treatment approach," said Sef Kurstjens, MD, PhD., chief medical officer at Astellas. The company says Astagraf is the first once-daily oral tacrolimus formulation available in the U.S. for kidney transplant recipients.
 
In two primary, randomized, comparative phase 3 clinical studies, Astellas enrolled 1,093 patients (545 on tacrolimus extended-release) in the U.S., Europe, Canada, South America, Australia and South Africa. Astellas was granted marketing approval for tacrolimus extended-release capsules under the trade name Advagraf^® in Europe in 2007 and under the trade name Graceptor^® in Japan in 2008. In total, tacrolimus extended-release capsules have been approved for use in 73 countries.