Genexine and NeoImmuneTech said Tuesday that the U.S. Food and Drug Administration has granted an orphan drug designation (ODD) to GX-I7, an immunotherapeutic drug candidate, in treating idiopathic CD4 + lymphocytopenia (ICL).
The FDA’s ODD is a system that helps smooth the development and approval of therapeutic drugs for rare or life-threatening diseases. ODD drugs receive tax holidays, exemption of license application fees, and seven-year monopoly after obtaining authorization.
The company said ICL dramatically decrease the number of immune cells that play a central role in the adaptive immune system of a person’s body without any specific disease. Such effect increases the possibility of the patient’s exposure to external lethal infection and the risk of cancer. As of now, there are no treatments to cure the disease.
The ODD comes after the company received an orphan drug status for the same indication from the European Medicines in May 2017.
With the FDA ODD, the company expects the drug candidate will become the first medication to treat ICL.
“GX-I7 is a fusion of cytokine interleukin-7, which plays an essential role in the proliferation of T cells in the body,” a company official said. “It can solve not only ICL but also the lymphocytopenia most commonly seen in cancer patients who received chemotherapy and radiation therapy.”
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