Extended indication Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP).
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Tebipenem
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Bacterial infections
Extended indication Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP).
Manufacturer Spero Therapeutics
Mechanism of action Antibiotic
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments Cell wall inhibitor.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional comments Indiennigsdatum op basis van primary completion datum fase 3 studie in mei 2020.

Therapeutic value

Current treatment options Meropenem of ceftazidime/avibactam
Therapeutic value No estimate possible yet
Substantiation Op dit moment zijn er nog weinig resultaten uit de trials bekend. Het is echter een interessant geneesmiddel aangezien het een carbepenem betreft dat oraal gegeven gaat worden. De inzet van meropenem neemt toe in het ziekenhuis waardoor patiënten uitbehandeld raken.
Duration of treatment Maximal 10 day / days
Frequency of administration 3 times a day
Dosage per administration 600 mg
References NCT03788967
Additional comments TBPM-PI-HBr 600 mg administered orally three times per day for 7 to 10 days.

Expected patient volume per year

References Nethmap 2017; Nivel; Inschatting Plazomicin;
Additional comments Afgelopen jaren is het meropenem gebruik verviervoudigd, mede gedreven door ESBL infecties, met name urineweginfecties. Incidentie urineweginfecties is 40-60/1.000 volwassen inwoners. In de Nederlandse huisartsenpraktijk bedraagt de incidentie van nierbekkenontsteking 30 tot 40 per 1.000 personen per jaar.

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
References adisinsight

Other information

There is currently no futher information available.