Orphan drug designation is granted to applicants when the prevalence of the disease occurs in less than 200,000 patients in the United States. The advantages of this designation include a waiver of the user fee, possible marketing exclusivity and tax credits for development costs. These advantages are intended to encourage sponsors to develop drugs for patients with rare diseases. SangStat submitted the Orphan Drug Designation Application for Thymoglobulin on May 5th 2000. Despite recent advances in immunosuppressive agents, from 20 percent to 60 percent of the 12,000 US patients who receive kidney transplants each year experience acute rejection during the first year following transplantation.
Acute rejection can often lead to the loss of the transplanted organ.
Thymoglobulin is a pasteurized anti-thymocyte rabbit immunoglobulin indicated for the treatment of renal transplant acute rejection, in conjunction with concomitant immunosuppression. Common adverse reactions, which are often transient, include fever, infections, and thrombocytopenia. Thymoglobulin is contraindicated in patients with known allergy to rabbit proteins, an acute viral illness, or a history of anaphylaxis during rabbit immunoglobulin administration. Thymoglobulin should only be used by physicians experienced in immunosuppressive therapy in the management of renal transplant patients. Any question regarding a medical diagnosis, treatment, referral, drug availability or pricing should be directed to either a licensed physician or to the product's manufacturer.