Rezolute (RZLT) announced the U.S. Food and Drug Administration, FDA, has granted Orphan Drug Designation, ODD, to ersodetug for the treatment of hypoglycemia due to tumor HI. “FDA’s granting of Orphan Drug Designation is a recognition of the serious unmet need patients with tumor hyperinsulinism face and validates the potential significant benefit that ersodetug can provide,” said Susan Stewart, J.D, Chief Regulatory Officer of Rezolute. “Tumor HI requires directed treatments for hypoglycemia to prevent serious adverse outcomes and improve patients’ quality of life, as well as to enable patients to continue cancer treatments. We are thrilled with FDA’s designation, which allows us to continue developing a potential universal treatment for hypoglycemia caused by all forms of HI.”
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