Rezolute Receives Orphan-Drug Designation from FDA for Low Blood Sugar Treatment

Dow Jones

Dec 03, 2024

By Connor Hart

Rezolute received an orphan-drug designation from the Food and Drug Administration for its treatment of hypoglycemia, or low blood sugar, caused by a disease in which a tumor produces too much insulin.

The Redwood City, Calif., company said Tuesday the treatment, ersodetug, is expected to start a Phase 3 registrational trial in 2025.

Ersodetug aims to treat tumor hyperinsulinism, a rare disease caused by two distinct types of tumors, both of which lead to low blood sugar as a result of excessive activation of the insulin receptor.

"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," said Chief Regulatory Officer Susan Stewart.

The FDA's orphan-drug designation encourages the development of treatments for rare diseases, offering benefits including seven years of market exclusivity protection and the potential qualification for expedited pathways to approval.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

December 03, 2024 08:40 ET (13:40 GMT)

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