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Abaloparatide

Eladynos

Extended indication Osteoporose voor postmenopauzale vrouwen
Therapeutic value No judgement
Total cost 22,500,000.00
Registration phase Negative CHMP opinion

Product

Active substance Abaloparatide
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Main indication Hormonal disorders
Extended indication Osteoporose voor postmenopauzale vrouwen
Proprietary name Eladynos
Manufacturer Radius
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date January 2016
Orphan drug No
Registration phase Negative CHMP opinion
Additional remarks Negatieve opinie CHMP maart 2018. Herbeoordeling gestart in april 2018. Negatieve opinie CHMP juli 2018.

Therapeutic value

Current treatment options teriparatide, denosumab
Therapeutic value No judgement
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 80 ug

Expected patient volume per year

Patient volume

< 1,500

Market share is generally not included unless otherwise stated.
References GIPdatabank
Additional remarks Denosumab zit nu op 20 miljoen met ruim 20000 gebruikers (voor alle indicaties) en teriparatide op 5 miljoen met 1500 gebruikers.

Expected cost per patient per year

Cost 10,000.00 - 20,000.00
References FiercePharma
Additional remarks In de VS wordt Tymlos ingezet op $19.500 pppj.

Potential total cost per year

Total cost

22,500,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Transdermal patch in ontwikkeling

Other information

There is currently no futher information available.