- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Rybelsus is a medicine used to control blood glucose (sugar) levels in adults whose type 2 diabetes is not controlled well enough. It can be used on its own when metformin (another medicine for diabetes) cannot be used, or in combination with other diabetes medicines. It should be used with an appropriate diet and physical exercise.
Rybelsus contains the active substance semaglutide.
Rybelsus is available as tablets (3, 7 and 14 mg) and can only be obtained with a prescription. The starting dose is 3 mg once daily. After one month, the dose should be increased to 7 mg once daily. If needed, the dose can be further increased up to a maximum of 14 mg once daily.
For more information about using Rybelsus, see the package leaflet or contact your doctor or pharmacist.
Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose in the blood or when the body cannot use insulin effectively. The result is a high level of glucose in the blood.
The active substance in Rybelsus, semaglutide, is a ‘GLP-1 receptor agonist’. It acts in the same way as GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food. This helps with the control of blood glucose levels.
Rybelsus was effective at controlling blood glucose levels in 7 main studies involving a total of over 5,500 patients with type 2 diabetes.
Depending on the dose, Rybelsus lowered HbA1c (showing improved blood glucose control) by between 0.6 and 1.4 percentage points. The results compared favourably with those with three other diabetes treatments empagliflozin, sitagliptin or liraglutide, which led to reductions of 0.9, 0.8, 0.9 percentage points, respectively. Rybelsus was also more effective than placebo (a dummy treatment).
In addition to better controlled blood glucose, patients taking Rybelsus had a beneficial reduction in body weight after 6 months. A further study in close to 3,200 patients suggested that Rybelsus may reduce the number of heart attacks and strokes compared to placebo, however, the difference was not statistically significant (it may be due to chance).
The most common side effects with Rybelsus (which may affect more than 1 in 10 people) are nausea (feeling sick), diarrhoea and low blood sugar levels (when used with insulin or a sulphonylurea).
For the full list of side effects and restrictions of Rybelsus, see the package leaflet.
Rybelsus is effective at controlling blood glucose levels in patients with type 2 diabetes and can also help patients reduce their weight. The most common side effects with Rybelsus affect the digestive system; the side effects are generally manageable and similar to those with an authorised injectable form of semaglutide (Ozempic).
As with the injectable form, there is a risk that Rybelsus could worsen some patients’ diabetic retinopathy (damage to the retina in the eye). Patients with this condition will therefore be monitored carefully.
The European Medicines Agency concluded that Rybelsus’ benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rybelsus have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Rybelsus are continuously monitored. Side effects reported with Rybelsus are carefully evaluated and any necessary action taken to protect patients.
Rybelsus received a marketing authorisation valid throughout the EU onon 3 April 2020.
Rybelsus : EPAR - Medicine overview
Reference Number: EMA/62316/2020
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Rybelsus : EPAR - Risk-management-plan summary
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Product information
Rybelsus : EPAR - Product information
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Latest procedure affecting product information: X/0038
01/08/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics(annex I);
- manufacturing authorisationholder responsible for batch release (annex IIA);
- conditions of themarketing authorisation(annex IIB);
- labelling(annex IIIA);
- package leaflet(annex IIIB).
Rybelsus : EPAR - All Authorised presentations
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Product details
- Name of medicine
Rybelsus
- Active substance
semaglutide
- International non-proprietary name (INN) or common name
semaglutide
- Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
- Anatomical therapeutic chemical (ATC) code
A10BJ06
Pharmacotherapeutic group
Drugs used in diabetes
Therapeutic indication
Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise
- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
- in combination with other medicinal products for the treatment of diabetes.
For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Authorisation details
- EMA product number
EMEA/H/C/004953
Additional monitoring
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
- Marketing authorisation holder
Novo Nordisk A/S
Novo Alle
Bagsværd - 2880
Denmark- Opinion adopted
30/01/2020
- Marketing authorisation issued
03/04/2020
- Revision
8
Assessment history
Rybelsus : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (191.83 KB - PDF)
First published: Last updated:
Rybelsus-EMEA-H-C-PSUSA-00010671-202205 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Reference Number: EMA/193544/2023
English (EN) (105.81 KB - PDF)
First published:
Rybelsus-EMEA-H-C-PSUSA-00010671-202005 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Reference Number: EMA/114770/2021
English (EN) (150.06 KB - PDF)
First published:
Rybelsus : EPAR - Public assessment report
AdoptedReference Number: EMA/95374/2020
English (EN) (4.28 MB - PDF)
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CHMP summary of positive opinion for Rybelsus
AdoptedReference Number: EMA/43724/2020
English (EN) (158.36 KB - PDF)
First published:
News on Rybelsus
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024
EMA statement on ongoing review of GLP-1 receptor agonists
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020
First oral GLP-1 treatment for type 2 diabetes
More information on Rybelsus
- Rybelsus - supply shortage
Topics
Medicines
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