fact sheet
- Active ingredient: Fingolimod
- Trade name: Gilenya®
- Therapeutic field: multiple sclerosis (diseases of the nervous system)
- Pharmaceutical entrepreneur: Novartis Pharma GmbH
time limits
- Start of proceedings: 01.01.2019
- Publication of the benefit assessment and start of the written comments stage: 01.04.2019
- Deadline for submission of written comments: 23.04.2019
- Resolution: 20.06.2019
- Procedure status: Procedure completed
Remarks and
Evaluation of benefits in accordance with Chapter 5, Section 1, Subsection 2, No. 2, of the VerfO
dossier
Documents submitted by the pharmaceutical company (procedure number 2019-01-01-E-412)
Appropriate comparative therapy
Field of application according to technical information for Fingolimod (Gilenya®)
Gilenya is indicated as a disease-modifying monotherapy of highly active relapsing-remitting multiple sclerosis in the following groups of adult patients and children and adolescents from the age of 10 years:
- Patients with highly active disease despite treatment with a complete and appropriate cycle with at least one disease-modifying therapy (see Sections 4.4 and 5.1 for exceptions and information on washout phases).
- Patients with rapidly progressive severe relapsing-remitting multiple sclerosis, defined as two or more relapses with disability progression in one year and with one or more gadolinium-enriching lesions in the MRI of the brain or with a significant increase in T2 lesions compared to a recent MRI.
Appropriate comparative therapy
For the appropriate comparative therapy, see the supporting reasons and the text of the decision in :
benefit assessment
The benefit assessment was published on 01.04.2019:
comments
The deadline for submitting written comments was 23.04.2019.
The oral hearing took place on 06.05.2019.
resolutions
Current version Pharmaceutical Directive/Annex XII:
The current version of the Medicines Directive/Annex XII on this active substance will be made available here shortly.
Medicines Directive/Plant XII: Fingolimod (new indication: paediatric patients with highly active relapsing-remitting multiple sclerosis)
Decision date: 20.06.2019 Entry into force: 20.06.2019 Decision published: BAnz AT 30.09.2019 B2
Related Procedures
Further evaluation procedures for this active substance:
English
Current Version Pharmaceutical Directive/Annex XII:
The current version of the Pharmaceutical Directive/Annex XII will shortly be available.
Pharmaceutical Directive/Annex XII: Fingolimod (New Therapeutic Indication: Paediatric Patients with Highly Active Relapsing-remitting Multiple Sclerosis)
Date of resolution: 20/06/2019 Entry into force: 20/06/2019
dossier
Documents submitted by the pharmaceutical company (procedure number 2019-01-01-E-412)
Appropriate comparative therapy
Field of application according to technical information for Fingolimod (Gilenya®)
Gilenya is indicated as a disease-modifying monotherapy of highly active relapsing-remitting multiple sclerosis in the following groups of adult patients and children and adolescents from the age of 10 years:
- Patients with highly active disease despite treatment with a complete and appropriate cycle with at least one disease-modifying therapy (see Sections 4.4 and 5.1 for exceptions and information on washout phases).
- Patients with rapidly progressive severe relapsing-remitting multiple sclerosis, defined as two or more relapses with disability progression in one year and with one or more gadolinium-enriching lesions in the MRI of the brain or with a significant increase in T2 lesions compared to a recent MRI.
Appropriate comparative therapy
For the appropriate comparative therapy, see the supporting reasons and the text of the decision in :
benefit assessment
The benefit assessment was published on 01.04.2019:
comments
The deadline for submitting written comments was 23.04.2019.
The oral hearing took place on 06.05.2019.
resolutions
Current version Pharmaceutical Directive/Annex XII:
The current version of the Medicines Directive/Annex XII on this active substance will be made available here shortly.
Medicines Directive/Plant XII: Fingolimod (new indication: paediatric patients with highly active relapsing-remitting multiple sclerosis)
Decision date: 20.06.2019 Entry into force: 20.06.2019 Decision published: BAnz AT 30.09.2019 B2
Related Procedures
Further evaluation procedures for this active substance:
English
Current Version Pharmaceutical Directive/Annex XII:
The current version of the Pharmaceutical Directive/Annex XII will shortly be available.
Pharmaceutical Directive/Annex XII: Fingolimod (New Therapeutic Indication: Paediatric Patients with Highly Active Relapsing-remitting Multiple Sclerosis)
Date of resolution: 20/06/2019 Entry into force: 20/06/2019