Rezolute, Inc. Receives FDA Orphan Drug Designation for Ersodetug for Hypoglycemia Due to Tumor Hyperinsulinism

Rezolute, Inc., a leading late-stage biopharmaceutical company focused on developing transformative therapies for rare diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ersodetug for the treatment of hypoglycemia due to tumor hyperinsulinism (HI). “This designation recognizes the serious unmet medical needs of patients with tumor hyperinsulinism and highlights the potential significant benefits that ersodetug can offer,” said Susan Stewart, J.D., Chief Regulatory Officer of Rezolute.

Publish Date: 03-12-2024 Source: Rezolute, Inc.

Hypoglycemia stands as the prevailing metabolic aberration observed in neonatal populations. The precise definition, clinical implications, and optimal management strategies for neonatal hypoglycemia remain subjects of ongoing debate. However, transient cases predominate, exhibiting prompt responsiveness to therapeutic interventions and generally portend an auspicious prognosis. Conversely, sustained hypoglycemic states are more inclined to accompany aberrant endocrine profiles, notably hyperinsulinemia, and potentially elicit neurological complications over the long term. Seizures represent a prominent manifestation of hypoglycemia, bearing the potential for consequential neuromorbidity. Among hypoglycemic conditions, insulin-induced hypoglycemia in diabetic individuals emerges as the most prevalent. Although insulinoma is a rare occurrence, it ranks as the most frequently encountered hormone-secreting islet cell tumor. Its diagnosis hinges upon the concurrence of hypoglycemia alongside neuroglycopenic symptoms, juxtaposed with disproportionately elevated levels of insulin and C-peptide. In hospitalized settings, the diagnosis is best ascertained through extended fasting protocols—most insulinomas present as diminutive lesions, necessitating invasive methodologies for precise localization. Hypoglycemia stemming from surreptitious insulin administration typically correlates with diminished plasma C-peptide levels. Postprandial hypoglycemia, precipitated by feeding, chiefly ensues from exaggerated insulin activity, commonly observed in postgastric surgery patients and, infrequently, in early-stage diabetes mellitus. Idiopathic postprandial hypoglycemia represents a rare entity attributed to subtle dysregulations in insulin response to dietary intake. Management strategies for postprandial hypoglycemia revolve around frequent, modest meals with restricted refined carbohydrate content and augmented protein intake. Surgical excision of the tumor constitutes the primary therapeutic avenue for addressing insulinoma.

However, the current Hypoglycemia treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Dasiglucagon, Mizagliflozin, Avexitide, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Hypoglycemia treatment. The key companies in the advanced development stage are Zealand Pharma, Vogenx, Inc., Eiger BioPharmaceuticals, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Hypoglycemia to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

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