Lomitapide

Lomitapide

Cardiovascular diseases

Indication extension

Lipid-lowering medications

Paediatric Patients With Homozygous Familial Hypercholesterolaemia (HoFH)

Lojuxta

Amryt

Capsule

Extramural (GVS)

Centralised (EMA)

No

2024

2025

Yes

Clinical trials

Evinacumab

Possible benefit in ease of use

Lomitapide heeft orale toediening (tabletten). Voor kinderen met HoFH met naaldenangst of die ver weg wonen van expertise centrum kan orale toediening een voordeel zijn ten opzichte van evinacumab dat 1 keer per maand intraveneus wordt toegediend.

1 times a day

20 - 60mg

NCT04681170

Age 5-10 years Lomitapide dosing will commence with 2mg at week 1 for 8 Weeks,then increase to 5mg Week 8±3 days, 10 mg at Week 12±3 days to the maximum allowable dose of 20 mg by Week 16±3 days or the MTD by Week 20±3 days based upon acceptable safety and tolerability criteria in addition to LDL C values
Intervention: Drug: Lomitapide
Age 11-15years Lomitapide dosing will commence with 2mg at week 1 for 4 Weeks, then increase to 5mg Week 4±3 days, 10 mg at Week 8±3 days,20mgs at week, 12±3 days to the maximum allowable dose of 40 mg by Week 16±3 days or the MTD by Week 20±3 days based upon acceptable safety and tolerability criteria in addition to LDL C values
Intervention: Drug: Lomitapide
16 to ≤17 years, Lomitapide dosing will commence with 5mg at week 1 for 4 Weeks, then increase to 10mg Week 4±3 days,20 mg at Week 8±3 days,40mgs at week, 12±3 days to the maximum allowable dose of 60 mg by Week 16±3 days or the MTD by Week 20±3 days based upon acceptable safety and tolerability criteria in addition to LDL C values
Intervention: Drug: Lomitapide

< 10

Market share is generally not included unless otherwise stated.

Record Evinacumab met indicatie: Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (HoFH).

Homozygote FH is een zeldzame aandoening. Er zijn ongeveer 50 patiënten in Nederland. Niet alle patiënten komen in aanmerking voor deze behandeling gezien zij uit zullen komen met andere behandelingen. Geschat aantal in Nederland is 10 patiënten.

< 774,000.00

medicijnkosten.nl

Voor de volwassen patiënten is er een financieel arrangement afgesloten.
Lojuxta capsule 20mg
Lomitapide Amryt pharmaceuticals dac

€ 776,86 per stuk vergoed. Bij een maximale dosis betekent dit dat de kosten jaarlijks €774.000 per patiënt zijn.

7,740,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.