Immunoforge (Co-CEOs Sung-min Ahn, Kiho Chang), a company specializing in developing new drugs for rare musculoskeletal diseases, has reported that their new drug candidate PF1801 has received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of Polymyositis.
The FDA designates solutions for rare incurable diseases or life-threatening diseases as Orphan Drugs. With this Orphan Drug Designation, Immunoforge will receive various benefits such as exemption from NDA/BLA application fees, tax credits for qualified clinical trials, and exclusive rights for seven years upon marketing approval.
Polymyositis is a disease in which muscles weaken due to inflammatory reactions; the cause of the disease has not yet been identified. Immunoforge states that “This Orphan Drug Designation is of great significance in confirming the potential of PF1801 as a treatment for rare musculoskeletal diseases, and we hope that it will serve as a source of hope for patients suffering from rare diseases with the various new drugs we are developing.”
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