Expand all sections

Lusutrombopag

Mulpleta

Extended indication Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures.
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Lusutrombopag
Domain Oncology and Hematology
Main indication Other hematology
Extended indication Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures.
Proprietary name Mulpleta
Manufacturer Shionogi
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Thrombopoietin receptor agonists

Registration

Registration route Centralised (EMA)
Particularity New medicine
Submission date February 2018
Expected Registration March 2019
Orphan drug No
Registration phase Registration application pending
Additional remarks L-PLUS-2 trail: effective and safe. Met all endpoints.

Therapeutic value

Therapeutic value No judgement
Duration of treatment Average 7 day / days
Frequency of administration 1 times a day
Dosage per administration 3 mg
References NCT02389621

Expected patient volume per year

References SPS; NHG-Standaard Virushepatitis en andere leveraandoeningen.
Additional remarks De incidentie van cirrose en andere leveraandoeningen in de huisartsenpraktijk is 0,6 per 1000 per jaar en de prevalentie 4,4 per 1000 per jaar. 76% van de cirrosepatiënten heeft thrombocytopenie. Dit betekent dat de totale incidentie 7.752 bedraagt en de prevalentie 56.848.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.