Extended indication Treatment of osteoporosis in postmenopausal women at increased risk of fracture
Therapeutic value No estimate possible yet
Total cost 22,500,000.00
Registration phase Positive CHMP opinion

Product

Active substance Abaloparatide
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Main indication Other metabolism and Endocrinology
Extended indication Treatment of osteoporosis in postmenopausal women at increased risk of fracture
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
Expected Registration December 2022
Orphan drug No
Registration phase Positive CHMP opinion
Additional comments Negatieve opinie CHMP maart 2018. Herbeoordeling gestart in april 2018. Negatieve opinie CHMP juli 2018. Positieve CHMP opinie ontvangen oktober 2022.

Therapeutic value

Current treatment options teriparatide, denosumab
Therapeutic value No estimate possible yet
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 comments Denosumab heeft momenteel ruim 20.000 gebruikers (voor alle indicaties) en teriparatide 1.500 gebruikers.

Expected cost per patient per year

Cost 10,000.00 - 20,000.00
References FiercePharma
Additional comments In de Verenigde Staten wordt Tymlos ingezet op $19.500 per patiënt per jaar.

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.