Immune Pharmaceuticals, Inc., a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to bertilimumab for the treatment of bullous pemphigoid (BP).
“We are incredibly gratified that bertilimumab has received Orphan Drug Designation for the treatment of bullous pemphigoid from the FDA and believe this designation, coupled with the recent positive opinion from the [European Medicines Agency] EMA’s Committee for Orphan Medicinal Products represent a significant regulatory milestone or bertilimumab,” commented Immune’s Chief Medical and Operating Officer, Tony Fiorino, MD, PhD. “We are focused on putting all of the manufacturing and regulatory pieces in place to launch a pivotal phase 2/3 study of bertilimumab in bullous pemphigoid next year.”
The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat, diagnose or prevent diseases and disorders that affect fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period, as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees.