2024-04-19 09:40:42
Meaning of ‘long-acting glucagon analogue using Hanmi LABSCOVERY technology’
Treatment for rare pediatric disease ‘congenital hyperinsulinemia’
Global phase 2 clinical trial in progress
Designated as an orphan drug by Korea, FDA, and EMA in recognition of innovation
Hanmi Science announced on the 18th that the International Nonspecific Name (INN) of Labs Glucagon Analog (HM15136), which Hanmi Pharmaceutical is developing as an innovative new drug for the treatment of congenital hyperinsulinemia, has been confirmed as ‘efpegerglucagon’. The name has been officially registered by the World Health Organization (WHO). In the future, the International Generic Name will be written as the ingredient name of the related drug (drug containing the relevant ingredient).
Epegerglucagon is a name created by adding the prefix ‘ef-‘ and the suffix ‘glucagon’ (glucagon receptor agonist). Epee, used as a prefix, refers to a protein applied with ‘LAPSCOVERY’, a Korea-US proprietary platform technology that dramatically increases the efficacy of biopharmaceuticals. To sum up, INN Epegerglucagon refers to ‘a long-acting glucagon analogue using LAPSCOVERY technology.’
Hanmi Pharmaceutical is developing Epegerglucagon as a treatment for congenital hyperinsulinemia in a once-weekly dosage form. Epegerglucagon is said to be the world’s first once-weekly dosage form in the field of congenital hyperinsulinemia treatment. Phase 2 global clinical trials are currently underway. When the new drug is finally commercialized, it is expected that it will greatly relieve patients’ pain and improve their quality of life in terms of durability of treatment effect, safety, and convenience of administration.
Congenital hyperinsulinemia is a rare disease that occurs in 1 in 25,000 to 50,000 people. Although there is one approved treatment to date, the treatment response rate is low, so patients are forced to use drugs other than those approved or rely on surgery to remove the pancreas at the risk of side effects. This disease, which mainly develops in the newborn period, causes persistent hypoglycemia, causing great pain not only to the patient but also to his or her family.
Based on its improved physicochemical and pharmacokinetic properties and the main physiological effects of glucagon receptor agonists (increased glycogenolysis and glucose synthesis), Epegerglucagon is used for the treatment of chronic hypoglycemic diseases such as post-bariatric surgery hypoglycemia (PBH) as well as congenital hyperinsulinemia. It is also attracting attention. In fact, in recognition of its innovation and potential, it was designated as an orphan drug for congenital hyperinsulinemia by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2018. The Ministry of Food and Drug Safety (MFDS) designated it as an orphan drug in 2019. Additionally, in 2020, it was selected as a pediatric orphan drug (RPD) by the FDA, and the EMA additionally designated it as an orphan drug with insulin autoimmune syndrome as an indication.
WHO grants INNs that can be used and recognized globally to specific pharmaceutical ingredients or substances in order to prevent misuse of pharmaceutical prescriptions and increase information delivery and convenience. Newly named INNs are periodically announced on the website.
In the case of Hanmi Pharmaceutical, in addition to efpeggerglucagon, the new bio drugs eflapegrastim (Rolbedone·Rolontis), efpeglenatide (LAPSExd4analog), efinopegdutide (LAPSGLP·GCGagonist), and Epoxy Many INNs, including efocipegtrutide (LAPSTripleagonist), have been listed by WHO.
Kim Min-beom, Donga.com reporter [email protected]
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2024-04-19 09:40:42