Immunomedics Says FDA Grants Orphan Drug Status For Veltuzumab To Treat ITP

(RTTNews) - Immunomedics Inc.(IMMU) announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted orphan status for the use of veltuzumab, the Company's humanized anti-CD20 antibody, for the treatment of immune thrombocytopenia or ITP.

In a Phase 1 study, low-dose veltuzumab, as a single agent, produced an objective response rate of 55% in 38 response-assessable patients with relapsed ITP, including 11 patients (29%) who reported a complete response. Furthermore, 10 responders achieved durable responses for more than 1 year, including 3 patients in remission for up to 4.3 years after veltuzumab treatment. The Phase 2 expansion trial has completed patient accrual and patients are being followed for up to 5 years.

ITP is an autoimmune disease in which the immune system attacks the platelets (or thrombocytes) resulting in their accelerated destruction. It is a bleeding disorder characterized by low blood platelet counts of less than 50,000/µL. The incidence of adult ITP is approximately 10-125 cases per 1,000,000 per year, and predominantly affects females with onset between 18 to 40 years of age.