Abbott Laboratories and SangStat have been granted Food and Drug Administration approval to market Abbott's Gengraf, a capsule form of cyclosporine that is bioequivalent to Novartis's Neoral capsules.
The drug will be used to prevent the rejection of transplanted kidneys, livers, and hearts. Abbott said in a statement that Gengraf would become available in pharmacies in late May and would be less expensive than Neoral.
Gengraf has been granted an AB rating by the FDA, which designates it as interchangeable with Neoral. However, Gengraf is not bioequivalent to Sandimmune, another Novartis cyclosporine product. Gengraf and Neoral were found to be bioequivalent in two studies. One study compared 100-mg Gengraf capsules with 100-mg Neoral capsules under fasting conditions, and the second study compared the drugs when they were administered with food.
In a different study, patients took Neoral twice daily for two weeks, Gengraf for two more weeks, and Neoral during the fifth weak. Twelve-hour pharmacokinetic profiles were obtained on treatment days 1, 14, 15, 28, and 29, and steady-state cyclosporine pharmacokinetic parameters did not change over time for either drug.
Abbott said that Gengraf may increase the susceptibility to infection and the development of neoplasia and can be toxic to the kidneys and liver. Patients receiving Gengraf will require frequent monitoring of kidney function. SangStat and Abbott also copromote the cyclosporine SangCya, an oral solution.
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For Your Information:
SangStat posts a statement at www.sangstat.com/press/press_release00-13.html, where links are available to additional information, including fact sheets about Gengraf and about the cost of transplantation therapy. Abbott posts the same statement at www.abbott.com/news/2000news/pr20000515.htm.
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