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Insulin oral

Extended indication Diabetes Type 2
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Insulin oral
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Main indication Diabetes
Extended indication Diabetes Type 2
Manufacturer Oramed
Portfolio holder Oramed
Route of administration Oral
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2024
Expected Registration 2025
Registration phase Clinical trials

Therapeutic value

Current treatment options insuline
Therapeutic value No estimate possible yet
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 18mg
References NCT04754334; Eldor R, Neutel J, Homer K, Kidron M. Efficacy and safety of 28-day treatment with oral insulin (ORMD-0801) in patients with type 2 diabetes: A randomized, placebo-controlled trial. Diabetes Obes Metab. 2021 Nov;23(11):2529-2538. doi: 10.1111/dom.14499. Epub 2021 Aug 18. PMID: 34310011.

Expected patient volume per year

Patient volume

< 1,000,000

Market share is generally not included unless otherwise stated.
References https://www.diabetesfonds.nl/over-diabetes/diabetes-in-het-algemeen/diabetes-in-cijfers
Additional remarks 1,2 miljoen Nederlanders hebben diabetes, dus 1 op de 14 Nederlanders. Iets meer mannen dan vrouwen. Naar schatting zijn er meer dan 1,1 miljoen Nederlanders met prediabetes, een voorfase van diabetes type 2. Daarnaast zijn er ook mensen die diabetes hebben, maar dit nog niet weten. Het is niet bekend hoe groot deze groep is. 52.000 Nederlanders per jaar horen dat ze diabetes hebben. Dat zijn 1.000 mensen per week, 150 per dag.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.