Cenegermin

Extended indication	Neurotrofische keratitis.
Therapeutic value	No judgement

Product

Active substance	Cenegermin
Domain	Neurological disorders
Main indication	Eye disorders
Extended indication	Neurotrofische keratitis.
Proprietary name	Oxervate
Manufacturer	Dompé
Route of administration	Ocular
Therapeutical formulation	Eye drops
Budgetting framework	Extramural (GVS)
Additional remarks	Werkingsmechanisme: 'Recombinant human nerve growth factor (rhNGF)'.

Registration route	Centralised (EMA)
Type of trajectory	Accelerated assessment
Submission date	December 2016
Expected Registration	July 2017
Orphan drug	Yes
Additional remarks	Oxervate geregistreerd bij de EMA voor Keratitis.

Therapeutic value	No judgement
Duration of treatment	Not found

Patient volume	< 7,140 Market share is generally not included unless otherwise stated.
References	EMA
Additional remarks	Neurotrophic keratitis affected approximately 4.2 in 10,000 people in the European Union (EU). Dit zijn 7.140 patienten per 17M Nederlanders.' (EMA)

Patient volume

< 7,140

Market share is generally not included unless otherwise stated.

References

EMA

Additional remarks

Neurotrophic keratitis affected approximately 4.2 in 10,000 people in the European Union (EU). Dit zijn 7.140 patienten per 17M Nederlanders.' (EMA)

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.