A new cyclosporine is about to come on the market in the United States.
The Food and Drug Administration has granted approval for SangStat, based here, to market SangCya, its cyclosporine formulation previously called Sang-35.
The launch of SangCya, expected in November or early December, will bring competition in the U.S. to Novartis' cyclosporine products, Sandimmune and Neoral. Sandimmune was introduced in 1983, and since Neoral was introduced in 1995, about 70% of patients taking Sandimmune have switched to Neoral.
"For the first time, the transplant community has the choice of a therapeutically equivalent drug for treating both new and established transplant patients with cyclosporine," said M. Roy First, MD, a SangCya clinical investigator and past president of the American Society of Transplant Physicians.
SangStat president Jean-Jacques Bienaime announced that SangCya will cost 20% less than Neoral capsules, "which should result in an average annual savings of $1200 per patient."
According to SangStat, SangCya's indications are identical to those of Neoral and include the prophylaxis of organ rejection in kidney, liver, and heart transplants; the treatment of patients with severe, active rheumatoid arthritis who have not adequately responded to methotrexate; and the treatment of nonimmunocompromised adults with severe plaque psoriasis for whom systemic therapy is not an option.
Studies demonstrating the bioequivalence of SangCya to Neoral have been published in the Journal of Clinical Pharmacology (1998;38:807-814) and Transplantation (1998;65:S13 and S66). Studies showing that patients using Sandimmune could be converted to SangCya have been published in Transplant Proceedings (1998;30:1701-1705).
For Your Information:
Complete prescribing information:
650-688-2331 (phone)SangStat press release:
http://www.sangstat.com/press_release98-22.htmlTransplant News Network:
"Patients Safely Switch Cyclosporines in Clinical Trial" (December 1, 1997)
"SangStat's Cyclosporine Projected to Boost Revenue" (July 1, 1998)
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