Extended indication Diabetes mellitus type 2
Therapeutic value No judgement
Registration phase Unknown

Product

Active substance Ertugliflozin (L-pyroglutamic acid) / sitagliptin (phosphate monohydrate)
Domain Metabolism and Endocrinology
Main indication Diabetes
Extended indication Diabetes mellitus type 2
Manufacturer MSD
Mechanism of action Unknown
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Samenwerking tussen MSD en Pfizer, MSD is de registratiehouder.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP Unknown
Submission date May 2017
Expected Registration April 2018
Orphan drug No
Registration phase Unknown

Therapeutic value

Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.

Substantiation Voor ertugliflozin/sitagliptin (een dpp-iv remmer) isgeen meerwaarde te verwachten tov de momenteel al op de markt zijnde combinatiepreparaten van een SGLT2 remmer met een dpp-iv remmer.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information