Today Biogen Idec BIIB announced new data from the second year of
its Phase 3 ADVANCE clinical trial that show the positive treatment effects of
PLEGRIDY™ (peginterferon beta-1a) were maintained in people with relapsing
forms of multiple sclerosis (RMS) beyond the first year of the study. These
results were presented at the sixth Triennial Joint Meeting of the Americas
Committee for Treatment and Research in Multiple Sclerosis and the European
Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS)
in Boston.
“These new, two-year data from ADVANCE further support the compelling efficacy
and safety of PLEGRIDY, providing physicians and patients with additional
confidence in the benefits of using PLEGRIDY to treat this chronic disease,”
said Gilmore O'Neill, vice president, Multiple Sclerosis Research and
Development at Biogen Idec.
Efficacy and Safety of PLEGRIDY Maintained Over Two Years
Post-hoc analyses from the two-year, Phase 3 ADVANCE clinical trial confirm
that PLEGRIDY's positive effects on reducing disease activity and disability
progression were maintained in year two of the study. A significantly higher
proportion of patients taking PLEGRIDY during both years of the study
experienced no evidence of disease activity (NEDA) – defined as the absence of
clinical and MRI disease activity over two years of treatment – compared to
those who switched to PLEGRIDY from placebo. Also, those treated with PLEGRIDY
for both years of the study had significant reductions in the risk of 24-week
confirmed disability progression compared to patients treated with placebo
during the first year.
In addition, new data from the second year of ADVANCE show that patients who
took PLEGRIDY throughout the study experienced statistically significant
improvements in clinical and MRI outcomes – including annualized relapse rate
(ARR), risk of relapse, risk of 24-week confirmed disability progression, and
number of brain lesions – when compared to those who switched to PLEGRIDY
after taking placebo for the first year. This new data also showed that the
safety profile of PLEGRIDY was consistent between years one and two of the
study.
“The ADVANCE data suggest that treatment with PLEGRIDY offers benefits in
reductions in relapses, confirmed disability progression and brain lesions
over the course of two years,” said Douglas Arnold, M.D., professor, Montreal
Neurological Institute, McGill University. “Results from the second year of
ADVANCE also confirm the positive safety and tolerability profiles of PLEGRIDY
seen in year one, which is very encouraging.”
These data will be presented in the following platform and poster
presentations:
* Clinical Efficacy of Peginterferon Beta-1a in Relapsing-Remitting Multiple
Sclerosis: 2-year Data from the Phase 3 ADVANCE Study (platform FC2.5)
will be presented on Friday, Sept. 12 at 9:00 a.m. ET
* Effect of Peginterferon Beta-1a on MRI Measures and Freedom from Measured
Disease Activity: 2-year Results from the Phase 3 ADVANCE Study (poster
P067) will be available for viewing on Thursday, Sept. 11 from 3:30-5:00
p.m. ET
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