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)
Copyright (c) 2024 Dow Jones & Company, Inc.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.