Extended indication Improving pregnancy rate following in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI
Therapeutic value Possibly no place in the treatment regimen
Registration phase No registration expected

Product

Active substance Nolasiban
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Main indication Other metabolism and Endocrinology
Extended indication Improving pregnancy rate following in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) procedures.
Manufacturer ObsEva
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments Oxytocine receptor antagonist

Registration

Registration route Centralised (EMA)
Orphan drug No
Registration phase No registration expected
Additional comments Fabrikant heeft de indicatie na tegenvallende resultaten teruggetrokken.

Therapeutic value

Therapeutic value Possibly no place in the treatment regimen
Substantiation Eindpunten van de fase 3 zijn niet gehaald.
Duration of treatment one-off
Dosage per administration 900 mg
References ObsEva persbericht 26 februari 2018; NCT03081208
Additional comments Eenmalige dosis nolasiban op 10 weken na embryo transfer.

Expected patient volume per year

References Freya.nl
Additional comments In 2016 werden er 14.584 IVF/ICSI-behandelingen uitgevoerd. Nolasiban zou bij een deel hiervan kunnen worden ingezet. Aangezien geen grote impact verwacht wordt, zal het mogelijk een klein aantal patiënten betreffen.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No

Other information

There is currently no futher information available.