Recombinant IVIG Granted Orphan Drug Designation for CIDP
- By BSTQ Staff
Pfizer (a licensee of Gliknik Inc.) has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its recombinant intravenous immune globulin (IVIG)-mimetic drug GL-2045 to treat chronic inflammatory demyelinating polyneuropathy (CIDP). FDA grants orphan drug designation to novel drugs or biologics that treat a disease or condition affecting fewer than 200,000 patients in the U.S. Several brands of the human blood product IVIG have previously received orphan drug designation for CIDP, but GL-2045 is a recombinant (not blood-derived) drug candidate under development. GL-2045 may eventually provide patients an alternative that is at least as effective as IVIG but potentially more convenient and safer without the risk of bloodborne pathogens. “This orphan drug designation is important in that it provides numerous incentives to develop GL-2045 to address an unmet need in CIDP, a rare neurological disorder,” said David Block, CEO of Gliknik.
