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.
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。