Version 3

Pretomanid

Medicine

Extended indication Dovprela is indicated in combination with bedaquiline, linezolid and moxifloxacin for the treatment of adults with pulmonary tuberculosis (TB) due to
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Pretomanid
Domain Infectious diseases
Reason of inclusion Indication extension IND
Main indication Bacterial infections
Extended indication Dovprela is indicated in combination with bedaquiline, linezolid and moxifloxacin for the treatment of adults with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to rifampicin, with or without resistance to isoniazid. Dovprela is indicated in combination with bedaquiline and linezolid for the treatment of adults with pulmonary TB due to M. tuberculosis resistant to rifampicin and a fluoroquinolone, with or without resistance to isoniazid (see sections 4.2, 4.4 and 5.1).
Proprietary name Dovprela
Manufacturer Global Alliance for TB Drug Development
Mechanism of action Antibiotic
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date March 2025
Expected Registration May 2026
Orphan drug Yes
Registration phase Registered
Additional remarks Positieve CHMP-opinie in december 2025.

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation Het lijkt een veelbelovend middel, maar er is nog te weinig data om de therapeutische waarde voor de Nederlandse praktijk mee in te schatten. Er is een andere fase 2 studie gepland (NCT06058299) waarin dit middel verder wordt onderzocht.
Duration of treatment Maximal 24 week / weeks
Frequency of administration 1 times a day
Dosage per administration 200 mg
References NCT02589782 (TB-PRACTECAL); Expertopinie

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Cost € < 3,800.00

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.
References Drugs.com (1); TB Alliance (2).
Additional remarks De prijs in de Verenigde Staten is €689 voor 26 tabletten (~€603) (1). Een behandeling van 24 weken zou dan €3.896 kosten in Nederland (€603/26∗24∗7). Via de Global Drug Facility wordt pretomanid geleverd voor $169 per behandeling (minder dan $1 per tablet) in lage- en middeninkomenslanden (2).

Potential total cost per year

Off label use

Indication extension

Other information