appears to have a positive effect and reduces disease progression in relapsing
multiple sclerosis, as demonstrated by the results of two phase 3 clinical
trials, the RADIANCE Part B and the SUNBEAM trial
- The results of
two phase 3 clinical trials, the SUNBEAM and the RADIANCE Part B, were
- The studies
evaluated the efficacy and safety of ozanimod as compared to interferon
beta-1a for the treatment of relapsing multiple sclerosis
- If the drug
receives approval from the regulatory authorities, it will provide an
additional option for patients with relapsing multiple sclerosis
. The results of the
study were presented at the 7th Joint European Committee for Treatment and
Research in Multiple Sclerosis-Americas Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS-ACTRIMS) 2017.
‘Two large clinical trials indicate better efficacy of ozanimod as compared to interferon beta-1a for the treatment of relapsing multiple sclerosis.
tried in patients with relapsing multiple sclerosis, where patients suffer
frequent flare-ups of the disease. The
effectiveness and safety of two doses, 0.5mg and 1 mg per day, were compared to
interferon beta-1a, which a drug that is currently being used to treat the
The RADIANCE Part B Study was conducted on 1320 patients for two
years, while the SUNBEAM Study was conducted on 1346 patients who were treated
for at least one year. The scientists found that:
- Both the doses
significantly reduced the annualized relapse rate (ARR) as compared to
patients on weekly injections of interferon β-1a.
- The number of new
and enlarging lesions due to multiple sclerosis in the brain, as
demonstrated on MRI, were significantly reduced to a greater extent in
patients taking ozanimod as compared to interferon
β-1a. Ozanimod significantly slowed the brain loss in the patients as
compared to interferon in patients taking 1 mg of ozanimod in the SUNBEAM
trial and with both the doses in the RADIANCE Part B trial.
- The side effects
including the serious effects were similar in the two groups. The most
common side effects with ozanimod in both the studies were
nasopharyngitis, headache, and upper respiratory tract infection.
manufacturing the drug hopes that they will be able to launch it soon in the
market, given its positive results in these two studies.
Ozanimod is a drug that
is a selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator.
It reduces inflammation and thereby prevents flare-ups in multiple sclerosis.
It is administered orally once a day. The drug is also likely to be tested in
inflammatory bowel disease that includes ulcerative colitis and Crohn's
Multiple SclerosisMultiple sclerosis
is an autoimmune disorder that
results in damage to the myelin sheath surrounding nerves. It causes various
neurological symptoms that frequently relapse ultimately resulting in
disability. Current treatments are aimed at modifying the course of the
disease, relieving symptoms and helping patients cope with the disability
through physical therapy.
- 7th Joint European Committee for Treatment and Research in Multiple Sclerosis-Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2017. Parallel Session 13, oral presentation 232. Multiple Sclerosis Journal 2017; 23: (S3) 8-84Late Breaking News session, oral presentation 280. Multiple Sclerosis Journal 2017; 23: (S3) 976-1023