Kinpeygo
Authorised
This medicine is authorised for use in the European Union
budesonide
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Kinpeygo is a medicine used to treat adults with primary immunoglobulin A nephropathy (IgAN). IgAN is a disease where the kidneys gradually stop working and eventually fail, requiring patients to undergo dialysis or have a kidney transplant. Kinpeygo is used in people who have at least 1 g of protein in their urine per day or a urine protein-to-creatinine ratio of at least 0.8 g/g (another measure of protein levels in the urine).
Kinpeygo is a ‘hybrid medicine’. It is similar to a ‘reference medicine’ containing the same active substance, but is used for a different disease and is given in a different way. The reference medicine for Kinpeygo is Entocort.
IgAN is rare, and Kinpeygo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 18 November 2016. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu-3-16-1778.
Kinpeygo contains the active substance budesonide.
Kinpeygo can only be obtained with a prescription and is available as capsules to be taken by mouth.
Kinpeygo is taken once a day for 9 months. The doctor may decide to repeat the 9-month cycle if necessary.
For more information about using Kinpeygo, see the package leaflet or contact your doctor or pharmacist.
IgAN is caused by the immune system (the body's natural defences) producing a faulty version of immunoglobulin A (IgA), a protein in the blood that identifies and attaches to specific foreign substances. In patients with this condition, faulty IgA builds up in the kidney, damaging them and preventing them from working properly.
The active substance in Kinpeygo, budesonide, is a corticosteroid. Corticosteroids have a wide range of effects that suppress the immune system. In particular, Kinpeygo is designed to release budesonide when it reaches the intestine, where it reduces the production of faulty IgA and thereby reduces IgA build-up and damage to the kidneys.
A main study involving 364 patients with IgAN showed that, after 9 months of treatment, patients taking Kinpeygo had a 34% reduction in proteinuria (excess protein in the urine, which can be a sign of kidney damage) compared with a 5% reduction in patients taking placebo (a dummy treatment). Long- term data showed that 15 months after the 9-month treatment period, patients who had received Kinpeygo had a 31% reduction in proteinuria compared with 1% for those who had received placebo. The study data also indicated that Kinpeygo slows the decline in kidney function, as seen in the change in estimated glomerular filtration rate (eGFR; a measure of how well the kidneys are working). A decrease in eGFR indicates a decline in kidney function. 15 months after the 9-month treatment period, eGFR had dropped by 7.5 ml/min/1.73m2 in people who had received Kinpeygo, compared with 13.5 ml/min/1.73m2 in those who had received placebo.
For the full list of side effects and restrictions with Kinpeygo, see the package leaflet.
The most common side effects with Kinpeygo include acne (which may affect around 1 in 10 people), and peripheral or facial oedema (build-up of fluids in the extremities or in the face), weight increase and increased levels of white blood cells, each of which may affect around 1 in 20 people. In clinical trials, these side effects were mild or moderate and resolved with time. For the full list of side effects of Kinpeygo, see the package leaflet.
Kinpeygo must not be used in patients with severe liver impairment (Child-Pugh Class C).
Kinpeygo has been shown to be effective at lowering the level of excess protein in the urine in patients with IgAN, and also appears to slow the decline in kidney function in adults with this disease.
Treatment with Kinpeygo was generally well tolerated, and side effects were in line with the known safety profile of budesonide.
The European Medicines Agency therefore decided that Kinpeygo’s benefits are greater than its risks and it can be authorised for use in the EU.
Kinpeygo was originally given ‘conditional authorisation’. The authorisation has now been switched to standard authorisation as the company has provided additional data requested by the Agency.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kinpeygo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Kinpeygo are continuously monitored. Suspected side effects reported with Kinpeygo are carefully evaluated and any necessary action taken to protect patients.
Kinpeygo received a conditional marketing authorisation valid throughout the EU on 19 May 2022. The conditional marketing authorisation was switched to a standard marketing authorisation on 24 July 2024.
Product information
Latest procedure affecting product information:
PSUSA/00011007/202312
25/09/2024
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 authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Kinpeygo
- Active substance
- budesonide, micronised
- International non-proprietary name (INN) or common name
- budesonide
- Therapeutic area (MeSH)
- Glomerulonephritis, IGA
- Anatomical therapeutic chemical (ATC) code
- A07EA06
Pharmacotherapeutic group
Antidiarrheals, intestinal antiinflammatory / antiinfective agentsTherapeutic indication
Kinpeygo is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g).
News on Kinpeygo
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