Document Detail

[Fingolimod compassionate use program: case study on the concept of a therapy option for multiple sclerosis prior to marketing approval].
MedLine Citation:
PMID:  23203160     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: In order to meet the needs of therapy of multiple sclerosis (MS) new immune therapies with a user-friendly application and better effectiveness together with good tolerability are necessary.
COMPASSIONATE USE: With respect to its potential to improve MS therapy, patients with a high medical need were given access to Fingolimod even before marketing approval. Therefore, a compassionate use program unique in the field of MS was initiated. In total 137 centers participated (75 % outpatient neurologists and 25 % hospitals). Within 19 weeks 135 patients were enrolled to receive Fingolimod. The patients in the compassionate use program can be representatively described as showing hardly controllable disease activity and progression with currently available, often poorly tolerated therapy. The compassionate use program for these patients offered better control of the disease with Fingolimod. The adverse events were as expected.
CONCLUSIONS: The Fingolimod compassionate use program demonstrated the need for this new therapeutic option. Patients who were not yet sufficiently treated were provided with an effective therapy with a good safety profile and a user-friendly administration form.
J Haas; R A Linker; H P Hartung; M Meergans; S Ortler; F Tracik
Publication Detail:
Type:  Case Reports; English Abstract; Journal Article; Multicenter Study    
Journal Detail:
Title:  Der Nervenarzt     Volume:  83     ISSN:  1433-0407     ISO Abbreviation:  Nervenarzt     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-18     Completed Date:  2013-07-09     Revised Date:  2013-07-15    
Medline Journal Info:
Nlm Unique ID:  0400773     Medline TA:  Nervenarzt     Country:  Germany    
Other Details:
Languages:  ger     Pagination:  1575-81     Citation Subset:  IM    
Klinik für Neurologie, Jüdisches Krankenhaus, Heinz-Galinski-Str. 1, 13347 Berlin, Deutschland.
Vernacular Title:
Fingolimod-Compassionate-use-Programm : Fallstudie zum Konzept einer Therapieoption bei Multipler Sklerose vor Zulassung und Markteinführung.
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MeSH Terms
Case-Control Studies
Compassionate Use Trials*
Drug Approval*
Drug Toxicity / epidemiology*
Europe / epidemiology
Immunosuppressive Agents / therapeutic use
Middle Aged
Multiple Sclerosis / diagnosis,  drug therapy*,  epidemiology*
Propylene Glycols / therapeutic use*
Sphingosine / analogs & derivatives*,  therapeutic use
Treatment Outcome
Reg. No./Substance:
0/Immunosuppressive Agents; 0/Propylene Glycols; 123-78-4/Sphingosine; 3QN8BYN5QF/fingolimod

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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