Prescribing information

 

See the long-term efficacy of GILENYA® ▼ (fingolimod) in clinical trials.

Mean EDSS score remained stable in adults at ≤3 over 7 years3

Mean EDSS score remained stable in adults at ≤3 over 7 years graph

Figure adapted from Cohen J et al. 2015.3
The analysis included all patients who received GILENYA 0.5 mg during the core or extension phases of GILENYA trials, including those who switched from comparator treatment during the respective core studies.

Using GILENYA earlier in the disease course offers greater ARR reduction4

Using GILENYA earlier in the disease course offers greater ARR reduction graph

Figure adapted from Agius M et al. 2014.4
Time since first RRMS symptom <3 years: absolute reduction in ARR was 0.233 (absolute values: 0.084 with GILENYA vs 0.317 with IFN β-1a).
Time since first RRMS symptom ≥3 years: absolute reduction in ARR was 0.221 (absolute values: 0.266 with GILENYA vs 0.487 with IFN β-1a).

Disease activity is significantly reduced within a year of switching in adults5

Disease activity is significantly reduced within a year of switching in adults graph

Figure adapted from Khatri B et al. 2011.5
Absolute reduction in number of T1 lesions was 0.4 (absolute values: 0.5 at Month 12 and 0.1 at Month 24).
Absolute reduction in brain volume loss was 0.23 (absolute values: −0.45 over Months 0–12 and −0.22 over Months 13–24).
TRANSFORMS extension core phase (Year 0–1) vs extension phase (Year 1–EOS).
§New or newly enlarged T2 lesions were reduced by 67%.

Reimbursement is available in the UK for the treatment of adults and paediatric patients with highly active RRMS with GILENYA. View the guidelines.

These links will take you to the NICE, SMC or AWMSG websites, which are non-Novartis websites.

 
 
 

TRANSFORMS: TRial Assessing Injectable INterferon vs fingolimod Oral in Relapsing-Remitting MS. TRANSFORMS was a 1-year, randomised, double-blind, double-dummy, active (interferon beta-1a)-controlled study of 1,292 adult patients with RRMS. Patients received either a daily dose of GILENYA or a weekly dose of 30 μg Avonex®.6

TRANSFORMS: Randomised Extension Study: A 1-year extension study of TRANSFORMS.5,6 A total of 1,027 patients entered the extension study and 882 patients completed the full 24 months of treatment. Patients originally randomly assigned to receive GILENYA continued with treatment at the same dose as in the core study, and patients originally assigned to receive interferon β-1a in the core study were randomly reassigned to receive GILENYA 0.5 mg or 1.25 mg.5

LONGTERMS: An open-label, single-arm, extension study evaluating the long-term safety, tolerability and efficacy of GILENYA in adult patients who previously participated in Phase 2, 3 or 3b GILENYA studies (including FREEDOMS, FREEDOMS II and TRANSFORMS).3

Indication: GILENYA is indicated as a single disease modifying therapy in highly active RRMS for the following groups of adult patients and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with ≥1 disease modifying therapy, or patients with RES RRMS defined by ≥2 disabling relapses in 1 year, and with 1 or more Gd+ lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.7

ARR, annualised relapse rate; AWMSG, All Wales Medicines Strategy Group; EDSS, expanded disability status scale; EOS, end of study; Gd+, gadolinium-enhancing; IFN β-1a: interferon beta-1a; MRI, magnetic resonance imaging; RES, rapidly evolving severe; RRMS, relapsing-remitting multiple sclerosis; NICE, National Institute for Health and Care Excellence; SMC, Scottish Medicines Consortium.

References

  1. Ziemssen T et al. Poster P6.393 presented at the 70th AAN Meeting, 21–27 April 2018, Los Angeles, CA, USA.
  2. Ziemssen T et al. Poster P5.365 presented at the 70th AAN Meeting, 21–27 April 2018, Los Angeles, CA, USA.
  3. Cohen JA et al. Poster P591 presented at the 31st Congress of the ECTRIMS, 7–10 October 2015, Barcelona, Spain.
  4. Agius M et al. CNS Neurosci Ther 2014;20:446–451.
  5. Khatri B et al. Lancet Neurol 2011;10(6):520–529.
  6. Cohen JA et al. N Engl J Med 2010;362:402–415.
  7. GILENYA (fingolimod) Summary of Product Characteristics.
GIL19-C053a(1) November 2020.
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