Astellas Pharma Inc.
) recently received approval for Astagraf XL (tacrolimus
extended-release capsules) in the U.S. for the prevention of
organ rejection in patients receiving a kidney transplant with
mycophenolate mofetil (MMF) and corticosteroids, with or without
Astagraf XL is the first once-daily oral tacrolimus
formulation to be approved in the U.S. for patients receiving a
The approval was based on two primary, randomized, comparative
phase III studies which enrolled 1,093 patients in the U.S.,
Europe, Canada, South America, Australia and South Africa.
This drug is already approved in the EU since 2007 under the
trade name Advagraf and in Japan since 2008 under the trade name
Graceptor. The drug is approved in 73 countries across the
We note that Astellas' Prograf (tacrolimus) is available in
the U.S. in the form of IV infusion to prevent organ rejection in
patients who have had a kidney, liver or heart transplant.
Prograf generated global sales of 161.7 billion yen in 2012,
including 49.4 billion yen from Japan, 31.4 billion yen from the
Americas, 57.5 billion yen from Europe and 18.9 billion yen from
Prograf patents expired in the U.S. in Apr 2008 and in major
European countries in Jun 2009.
Currently, Prograf faces generic competition in the U.S.
Generic versions of Prograf were launched by companies like
Dr. Reddy's Laboratories Ltd.
Astellas carries a Zacks Rank #4 (Sell). Right now,
Jazz Pharmaceuticals Public Limited Company (
looks well positioned with a Zacks Rank #1 (Strong Buy).
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