Nolasiban

Active substance
Nolasiban
Domain
Metabolism and Endocrinology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Other metabolism and Endocrinology
Extended indication
Improving pregnancy rate following in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) procedures.

1. Product

Manufacturer
ObsEva
Mechanism of action
Receptor antagonist
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Extramural (GVS)
Additional comments
Oxytocine receptor antagonist

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials
Additional comments
Eerste resultaten van de fase 3 IMPLANT4 studie worden verwacht in december 2019.

3. Therapeutic value

Therapeutic value
No judgement
Substantiation
Primary endpoint gehaald. Absolute toename aantal zwangerschappen na 10 weken met 7,1% met nolasiban versus placebo. De verwachting is dat de impact niet groot is.
Dosage per administration
900 mg
References
ObsEva persbericht 26 februari 2018; NCT03081208
Additional comments
Eenmalige dosis nolasiban op 10 weken na embryo transfer.

4. 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.

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

Indication extension
No

9. Other information

There is currently no futher information available.