ent and statistically significant reduction of annualized relapse rate compared to comparator in subgroups defined by gender, age, prior MS therapy, and disease activity.
Table 2 Clinical and MRI Results of Study 1 GILENYA 0.5 mg N=425 Placebo N=418 p-value
Clinical Endpoints
Annualized relapse rate (primary endpoint) 0.18 0.40 <0.001
Percentage of patients without relapse 70% 46% <0.001
Hazard ratio‡ of disability progression
(95% CI) 0.70
(0.52, 0.96) 0.02
MRI Endpoint
Mean (median) number of new or newly enlarging T2 lesions over 24 months 2.5(0) 9.8 (5.0) <0.001
Table 3 Clinical and MRI Results of Study 2 GILENYA 0.5 mg N=429 Interferon beta-1a IM 30 μg N=431 p-value
Clinical Endpoints
Annualized relapse rate (primary endpoint) 0.16 0.33 <0.001
Percentage of patients without relapse 83% 70% <0.001
Hazard ratio‡ of disability progression
(95% CI) 0.71
(0.42, 1.21) 0.21
MRI Endpoint
Mean (median) number of new or newly enlarging T2 lesions over 12 months 1.6 (0) 2.6 (1.0) 0.002
0.5 mg GILENYA capsules are hard gelatin capsules with a white opaque body and bright yellow cap imprinted wit
Manufacturer
Novartis Pharmaceuticals Corporation (NPC), a US subsidiary of Novartis AG
Active Ingredients
Source
U.S. National Library of Medicine
DailyMed
Last Updated: 2nd of March 2011
