Hyperinsulinemic hypoglycemia

Eiger Announces FDA Breakthrough Therapy Designation for Avexitide for Treatment of Congenital Hyperinsulinism

Retrieved on: 
Thursday, August 5, 2021
MD, Learning, Brain damage, Insulin, Lists of diseases, Hyperinsulinemic hypoglycemia, Pancreas, Viral hepatitis, Review, HI, Patient, Eiger, Inborn errors of metabolism, EMA, LILO (boot loader), Metabolic disorder, Food and Drug Administration, Hepatitis, Congenital hyperinsulinism, Risk, Lonafarnib, III, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Nasdaq, Compliance, Death, Fasting, Birth defect, Hypoglycemia, Paro Airport, Food, HDV, Pharmaceutical industry

Eiger's application was supported by data from three completed Phase 2 studies in 39 neonates, children and adolescents with congenital hyperinsulinism.

Key Points: 
  • Eiger's application was supported by data from three completed Phase 2 studies in 39 neonates, children and adolescents with congenital hyperinsulinism.
  • "Avexitide represents a promising, targeted approach for the treatment of congenital hyperinsulinism, an urgent, unmet medical need with no approved therapy," said Colleen Craig, MD, Vice President of Metabolic Diseases at Eiger.
  • Avexitide has been granted Breakthrough Therapy Designation by the FDA for the treatment of congenital hyperinsulism, Orphan Drug Designation by the FDA for the treatment of hyperinsulinemic hypoglycemia (which includes congenital hyperinsulinism), Orphan Drug Designation by the EMA for the treatment of congenital hyperinsulinism and Rare Pediatric Disease Designation by the FDA.
  • Avexitide has been granted Breakthrough Therapy Designation by the FDA, as well as Orphan Drug Designation by the FDA for the treatment of hyperinsulinemic hypoglycemia and Orphan Drug Designation by the EMA for the treatment of non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS).

Xeris Pharmaceuticals Receives U.K. MHRA Approval of Ogluo® (glucagon) Injection for the Treatment of Severe Hypoglycaemia in Adults, Adolescents, and Children Aged 2 Years and Over With Diabetes Mellitus

Retrieved on: 
Thursday, April 29, 2021
Diabetes, Pharmaceutical, Health, Endocrine diseases, Diabetes, Organ systems, Endocrine system, Medical emergencies, Hypoglycemia, Idiopathic postprandial syndrome, Glucagon, Diabetic hypoglycemia, Hyperinsulinemic hypoglycemia, Glucagon, Severe Hypoglycemia, Xeris Pharmaceuticals, Inc., GLUCAGON, SEVERE HYPOGLYCEMIA, XERIS PHARMACEUTICALS, INC.

Gvoke is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above.

Key Points: 
  • Gvoke is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above.
  • If a patient develops symptoms of hypoglycemia after a dose of Gvoke, give glucose orally or intravenously.\nAllergic reactions have been reported with glucagon.
  • Gvoke is contraindicated in patients with a prior hypersensitivity reaction.\nGvoke is effective in treating hypoglycemia only if sufficient hepatic glycogen is present.
  • Severe hypoglycemia is characterized by severe cognitive impairment, requiring external assistance for recovery, and can be extremely frightening for patients and caregivers.

Vertex Announces FDA Fast Track Designation and Initiation of a Phase 1/2 Clinical Trial for VX-880, a Novel Investigational Cell Therapy for the Treatment of Type 1 Diabetes

Retrieved on: 
Wednesday, March 10, 2021
Biotechnology, Diabetes, Health, Pharmaceutical, Clinical trials, Clinical medicine, Diabetes, Endocrine system, Organ systems, Insulin, Type 1 diabetes, Hypoglycemia, Blood sugar level, Pancreatic islets, Hyperinsulinemic hypoglycemia, VX-880, the Phase 1/2 Clinical Trial, Type 1 Diabetes, Vertex

VX-880 has the potential to restore the bodys ability to regulate glucose levels by restoring pancreatic islet cell function, including insulin production.

Key Points: 
  • VX-880 has the potential to restore the bodys ability to regulate glucose levels by restoring pancreatic islet cell function, including insulin production.
  • The clinical trial is a Phase 1/2, single-arm, open-label study in patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia.
  • This will be a sequential, multi-part clinical trial to evaluate the safety and efficacy of different doses of VX-880.
  • Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

Crinetics Pharmaceuticals Receives Rare Pediatric Disease Designation from FDA for CRN04777 for the Treatment of Congenital Hyperinsulinism

Retrieved on: 
Monday, September 21, 2020
Endocrine system, Organ systems, Clinical medicine, RTT, Diabetes, Hypoglycemia, Insulin, Blood sugar level, Hyperinsulinemic hypoglycemia, Hyperinsulinism

Congenital HI is a devastating rare disease in which infants are born with life threatening hypoglycemia (low blood glucose) due to excess insulin secretion.

Key Points: 
  • Congenital HI is a devastating rare disease in which infants are born with life threatening hypoglycemia (low blood glucose) due to excess insulin secretion.
  • CRN04777 is the first oral, selective nonpeptide SST5 receptor agonist designed to reduce insulin secretion and is intended to be a universal treatment for all patients with congenital HI.
  • The receipt of this RPD designation points to the seriousness of the disease for which there is an enormous need for new treatment options.
  • While this is a rare disease, congenital HI is a leading cause of persistent hypoglycemia in infants and children.

Zealand Pharma presents clinical and non-clinical evidence for dasiglucagon rescue therapy at the 80th Scientific Sessions of the American Diabetes Association

Retrieved on: 
Sunday, June 14, 2020
RTT, Organ systems, Endocrine system, Medicine, Eli Lilly and Company, Diabetes, Hypoglycemia, Insulin, Glucagon, Type 1 diabetes, Hyperinsulinemic hypoglycemia, Diabetic hypoglycemia

Dasiglucagon, a potential first-in-class soluble glucagon analog invented and developed by Zealand Pharma, has the potential to offer millions of people living with diabetes fast and effective treatment for severe hypoglycemia.

Key Points: 
  • Dasiglucagon, a potential first-in-class soluble glucagon analog invented and developed by Zealand Pharma, has the potential to offer millions of people living with diabetes fast and effective treatment for severe hypoglycemia.
  • It has been developed in the ready-to-use HypoPal rescue pen for easy, fast and effective treatment.
  • This Phase 3 parallel, two-arm study in 45 adults with Type 1 diabetes, investigated the recovery from insulin-induced hypoglycemia with dasiglucagon versus placebo.
  • More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market.

Rezolute Presents RZ358 Clinical Data-Validated Model of the Pharmacokinetics and Glycemic Response in Congenital Hyperinsulinism at Pediatric Endocrine Society 2020 Annual Meeting

Retrieved on: 
Monday, June 1, 2020
Endocrine diseases, Organ systems, Hyperinsulinism, Congenital hyperinsulinism, Pancreas, Endocrine system, Hyperinsulinemic hypoglycemia

The data were accepted as an oral presentation at the Pediatric Endocrine Society (PES) 2020 Annual Meeting, held virtually.

Key Points: 
  • The data were accepted as an oral presentation at the Pediatric Endocrine Society (PES) 2020 Annual Meeting, held virtually.
  • Its lead clinical asset, RZ358, is in Phase 2b development as a potential treatment for congenital hyperinsulinism, a rare pediatric endocrine disorder.
  • Congenital hyperinsulinism is a rare, genetic, pediatric endocrine disorder that leads to the inappropriate secretion of the hormone insulin by the pancreas.
  • Rezolute is currently evaluating RZ358 in the RIZE trial, a Phase 2b clinical trial in patients with CHI.

Global Congenital Hyperinsulinism Clinical Development Scenario and Market Growth Prospects 2020 - ResearchAndMarkets.com

Retrieved on: 
Monday, April 20, 2020
Diabetes, Pharmaceutical, Health, Medicine, Hyperinsulinism, Congenital hyperinsulinism, Medical specialties, Disease, Articles, Hyperinsulinemic hypoglycemia

Congenital Hyperinsulinism Pipeline Insight, 2020 outlays comprehensive insights of present clinical development scenario and growth prospects across the Congenital Hyperinsulinism market.

Key Points: 
  • Congenital Hyperinsulinism Pipeline Insight, 2020 outlays comprehensive insights of present clinical development scenario and growth prospects across the Congenital Hyperinsulinism market.
  • A detailed picture of the Congenital Hyperinsulinism pipeline landscape is provided, which includes the disease overview and Congenital Hyperinsulinism treatment guidelines.
  • The assessment part of the report embraces in-depth Congenital Hyperinsulinism commercial assessment and clinical assessment of the Congenital Hyperinsulinism pipeline products from the pre-clinical developmental phase to the marketed phase.
  • How many Congenital Hyperinsulinism emerging therapies are in early-stage, mid-stage, and late stage of development for the treatment of Congenital Hyperinsulinism?

Zucara Therapeutics Announces US$21 Million Series A Financing

Retrieved on: 
Tuesday, March 31, 2020
Endocrine system, Medicine, Eli Lilly and Company, Organ systems, RTT, Diabetes, Peptide hormones, Recombinant proteins, Insulin, Hypoglycemia, Diabetes management, Hyperinsulinemic hypoglycemia

TORONTO, March 31, 2020 (GLOBE NEWSWIRE) -- Zucara Therapeutics Inc., a diabetes life sciences company developing the first once-daily therapeutic to prevent insulin-induced hypoglycemia (low blood glucose levels), today announced that it has closed a US$21 million Series A Financing led by the Perceptive Xontogeny Venture Fund (PXV Fund).

Key Points: 
  • TORONTO, March 31, 2020 (GLOBE NEWSWIRE) -- Zucara Therapeutics Inc., a diabetes life sciences company developing the first once-daily therapeutic to prevent insulin-induced hypoglycemia (low blood glucose levels), today announced that it has closed a US$21 million Series A Financing led by the Perceptive Xontogeny Venture Fund (PXV Fund).
  • Hypoglycemia is associated with significant morbidity and mortality, yet there are currently no available therapeutics to prevent the condition.
  • Zucara is currently preparing to initiate a Phase 1 clinical trial of ZT-01 in mid-2020.
  • Zucara Therapeutics is developing ZT-01, a first-in-class, once-daily therapeutic to prevent insulin-induced hypoglycemia in patients using insulin therapy.

Diasome to Present Additional Data on Hepatocyte Directed Vesicle Technology in Type 1 Diabetes at the Advanced Technologies & Treatment for Diabetes International Conference

Retrieved on: 
Wednesday, February 12, 2020
Endocrine system, Hormones, Medicine, Eli Lilly and Company, RTT, Peptide hormones, Recombinant proteins, Diabetes, Insulin, Hypoglycemia, Hyperinsulinemic hypoglycemia

Recent severe hypoglycemia and impaired hypoglycemia awareness were exclusionary.

Key Points: 
  • Recent severe hypoglycemia and impaired hypoglycemia awareness were exclusionary.
  • The ePoster will be made available on the Diasome website, www.diasome.com , following the presentation.
  • Diasomes hepatocyte directed vesicle (HDV) technology is the only pharmaceutical insulin additive being developed to prevent hypoglycemia by restoring normal liver physiology in patients with diabetes.
  • HDV technology is a Phase 3-ready asset designed to improve the safety and efficacy of all insulins.

Eiger Announces Breakthrough Therapy Designation Granted by FDA for Avexitide for Treatment of Post-Bariatric Hypoglycemia (PBH)

Retrieved on: 
Monday, June 17, 2019
Health, Articles, Organ systems, Food and Drug Administration, Breakthrough therapy, Pharmacy, Laminopathy, Progeria, Fast track, Hyperinsulinemic hypoglycemia, Orphan drug

FDA Breakthrough Therapy Designation involves a fast track development and FDA review process with guidance designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases.

Key Points: 
  • FDA Breakthrough Therapy Designation involves a fast track development and FDA review process with guidance designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases.
  • Avexitide is a targeted, first-in-class, GLP-1 antagonist in development for the treatment of PBH, a chronic, debilitating disorder for which there is no approved treatment.
  • "We look forward to continued collaboration with the FDA, now on three Breakthrough Therapy Designation programs including lonafarnib for hepatitis delta virus (HDV) infection, lonafarnib for Hutchinson-Gilford Progeria Syndrome (Progeria) and Progeroid Laminopathies, and avexitide for post-bariatric hypoglycemia (PBH)."
  • Avexitide has been granted Breakthrough Therapy Designation by the FDA, as well as Orphan Drug Designation in the U.S. by the FDA for the treatment of hyperinsulinemic hypoglycemia and Orphan Drug Designation by the EMA for the treatment of non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS).