15 March 2001 18:54 [Source: ICIS news]
HOUSTON (CNI)--Wyeth-Ayerst Laboratories (WAL) said Thursday it has received market approval from the 15-nation European Union (EU) for its post-surgical organ rejection therapeutic Rapamune (sirolimus).
Madison, New Jersey-based WAL, the pharmaceuticals division of American Home Products (AHP), said market approval by the EU executive, the European Commission (EC), came following evaluation of data from clinical studies of Rapamune's use with more than 2500 patients.
Rapamune is the first in a distinct class of immunosuppressant agents developed for the prevention of organ rejection following kidney transplantation, WAL noted. The EC approval recommended that Rapamune be indicated for treatment of "organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant."
WAL said that kidney transplantation is the most common type of organ transplantation procedure in Europe, with more than 13 000 transplants taking place in 1997. Immunosuppressant drugs such as Rapamune typically are prescribed as a life-long regimen for kidney-transplant patients to allow the transplanted organ to remain functional.
Rapamune was approved for use in the US in late 1999 and also is approved in several Latin American countries, South Africa, Taiwan and Canada. The drug is awaiting approval in Russia.
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