FDA FINDS ASTELLAS' DRUG APPROVABLE FOR TWO OUT OF THREE INDICATIONS

Astellas Pharma announced it has received an action letter from the FDA regarding the company's new drug application (NDA) for its once-daily immunosuppressant FK506 modified-release formulation (tacrolimus).

The action letter addresses each of the three target indications contained in the NDA, which are the prophylaxis for organ rejection in kidney, liver and heart transplant patients. The FDA found the first two indications, involving kidney and liver transplant patients, approvable. The agency deemed the third, the prophylaxis of organ rejection in heart transplant patients, not approvable.

The FDA also raised additional questions for each of the three indications. Astellas said it is internally reviewing the comments outlined in the action letters and is working with the FDA to address the issues and secure approval of FK506 MR.

Tacrolimus is an immunosuppressant developed by Astellas. The twice-daily formulation, Prograf, is approved in roughly 70 countries. FK506 is a modified-release formulation that can be administered once a day.

Astellas submitted the NDA for FK506 in December 2005. The company has also submitted applications for regulatory approval in Japan and Europe.