Kaliumcitraat / kaliumwaterstofcarbonaat

Active substance
Kaliumcitraat / kaliumwaterstofcarbonaat
Domain
Metabolism and Endocrinology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Metabolic diseases
Extended indication
Adults and Children Suffering from distal Renal Tubular Acidosis (dRTA)

1. Product

Manufacturer
Advicenne
Mechanism of action
Other
Route of administration
Oral
Therapeutical formulation
Granulate
Budgetting framework
Extramural (GVS)
Additional comments
Kaliumcitraat / kaliumwaterstofcarbonaat heeft een alkaliserende werking zodat de zuurtegraad in de patiënt wordt teruggebracht.

2. Registration

Registration route
Centralised (EMA)
Particularity
New therapeutical formulation
Submission date
2019
Expected Registration
2020
Orphan drug
Yes
Registration phase
Clinical trials

3. Therapeutic value

Current treatment options
Alkaliserende middelen om de zuurtegraad van het lichaam in stand te houden zoals natriumbicarbonaat, natriumcitraat en kaliumcitraat.
Therapeutic value
No judgement
Substantiation
Huidige behandeling moet iedere 4-6 uur worden ingenomen. Deze formulering werkt 12 uur en hoeft dus maar 2 maal per dag te worden ingenomen en is smaakloos. Met name gericht op kindvriendelijke toediening.
Frequency of administration
2 times a day
References
Scrip

4. Expected patient volume per year

Patient volume

< 4,000

Market share is generally not included unless otherwise stated.

References
EMA
Additional comments
At the time of designation, distal renal tubular acidosis affected approximately 2.1 in 10,000 people in the European Union (EU). Dit zou neerkomen op 3.570 patiënten in Nederland

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.