FDA grants orphan drug designation to Novel GLP-1 Receptor Agonist for Polymyositis
SEOUL, South Korea - The US Food and drug administration has granted Orphan Drug Designation to new drug candidate PF1801for 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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