Recent regulatory news has included approvals for Wyeth-Ayerst Laboratories, Schering-Plough, and Abiomed Inc.
* Wyeth-Ayerst Laboratories of Madison, N.J., announced on March 15 that Rapamune (sirolimus) has received marketing authorization from the European Commission, representing 15 European countries. Wyeth said that the European Commission recommend that Rapamune be indicated "for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant." Rapamune, the first in a class of immunosuppressant agents developed for the prevention of organ rejection following renal transplantation, was approved in the United States in September 1999 and also has been approved in more than a dozen other countries, including Canada. In August 2000, Rapamune was approved for use in tablet form in the United States.
* According to ICN Pharmaceuticals, Schering-Plough has announced that the European Commission has granted centralized marketing authorization to Peg-Intron (peginterferon alfa-2b) injection and Rebetol (ribavirin) capsules as combination therapy for the treatment of both relapsed and previously untreated adults with histologically proven chronic hepatitis C. A study on which the decision was based showed that combination therapy with Peg-Intron and Rebetol was significantly more effective (61% vs 47%) in achieving a sustained virologic response than the combination of Rebetol and Intron-A (interferon alfa-2b).
* Abiomed Inc. of Danvers, Massachusetts, said on March 27 that the Food and Drug Administration has approved the use of the company’s BVS-5000 Bi-Ventricular Support System in a new place in the heart—with the apex of the natural heart’s left ventricle as the site of access to blood, which allows surgeons the flexibility to support failing hearts by accessing blood via either the left atrium or the left ventricle. Abiomed said it requested the approval from the FDA because many surgeons using the BVS had indicated a preference for this alternative mode of surgical access.
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