FDA Grants Orphan Drug Status For Immunomedics' Veltuzumab To Treat Pemphigus

(RTTNews) - Immunomedics, Inc., (IMMU) said Friday that the U.S. Food and Drug Administration has granted orphan drug status for the use of veltuzumab, the company's humanized anti-CD20 antibody, for the treatment of pemphigus.

Pemphigus is a debilitating and potentially fatal autoimmune blistering disease of the skin and mucous membranes. In most cases, irregularly-shaped, painful erosions or lesions (ulcerations) initially develop in the mucous membranes lining the inside of the mouth. To maintain disease control typically requires long-term exposure to corticosteroids and other drugs which suppress the immune system and may themselves contribute to osteoporosis, septicemia, and other serious adverse events seen in this population.

Orphan drug status is granted by FDA to a drug or biological product to treat a rare disease or condition upon request of a sponsor. Orphan drug designation qualifies the company for various development incentives, including tax credits for qualified clinical testing, a waiver from FDA's application User Fee for marketing application, and a seven-year period of marketing exclusivity in the United States for veltuzumab, if it is approved by FDA for the treatment of patients with pemphigus.