– Analyses Reinforce Efficacy of PLEGRIDY, Further Supporting a Potential New Treatment Option for People with Multiple Sclerosis –
“If approved, PLEGRIDY could become a valuable addition to the
interferon class of multiple sclerosis therapies,” said Professor
Improvements Seen in Clinical and MRI Endpoints
Over one year, absence of measured disease activity (defined as no relapses, no disability progression, no gadolinium-enhancing [Gd+] lesions and no new or newly enlarging T2-hyperintense lesions compared to baseline) among patients, was significantly higher with PLEGRIDY: 34 percent in the two-week dosing arm (p<0.0001) and 22 percent in the four-week dosing arm (p=0.01), compared to 15 percent in the placebo arm.
In the intent-to-treat population of the ADVANCE study, PLEGRIDY, when dosed every two weeks, significantly reduced the number of new or newly enlarging T2-hyperintense lesions, new T1-hypointense lesions, new Gd+ lesions and new active lesions compared to placebo at 48 weeks. Specifically, PLEGRIDY reduced the number of:
- New T1-hypointense lesions by 53 percent in the two-week dosing arm (p<0.0001) and 18 percent in the four-week dosing arm (p=0.082), ns
- New active lesions by 67 percent in the two-week dosing arm (p<0.0001) and 35 percent in the four-week dosing arm (p<0.0001)
And, as previously reported at the
- New or newly enlarging T2-hyperintense lesions by 67 percent in the two-week dosing arm (p<0.0001) and 28 percent in the four-week dosing arm (p=0.0008)
- New Gd+ lesions by 86 percent in the two-week dosing (p<0.0001) and 36 percent in the four-week dosing arm (p=0.07), ns
“We believe the new analyses reinforce the efficacy of PLEGRIDY, which
has been shown consistently across key MS disease measurements. They
further support its potential as a treatment option for people living
with this disease,” said Gilmore O’Neill, vice president,
Clinical and MRI results, including a post-hoc analysis evaluating the
absence of measured disease activity from year one of the ADVANCE study,
will be presented in the poster session titled,
“Immunomodulation/Immunosuppression,” on Thursday, 3 October at
- Peginterferon Beta-1a Provides Improvements in Clinical and Radiological Disease Activity in Relapsing Multiple Sclerosis: Year 1 Findings from the Phase 3 ADVANCE Study (poster 514)
Additional MRI results from the first year of ADVANCE will be presented
in the poster session titled, “II Immunomodulation/Immunosuppression,”
on Friday, 4 October at
- Magnetic Resonance Imaging Results from the First Year of the ADVANCE Study, a Pivotal Phase 3 Trial of Peginterferon Beta-1a in Patients with Relapsing-Remitting Multiple Sclerosis (poster 989)
PLEGRIDY is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body. PLEGRIDY is a member of the interferon class of treatments, which is often used as a first-line treatment for MS.
Regulatory authorities in
The two-year Phase 3 ADVANCE clinical trial is a global, multi-center, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the efficacy and safety of PLEGRIDY in 1,516 patients with relapsing-remitting MS. The study investigates two dose regimens of PLEGRIDY: 125 mcg administered subcutaneously every two weeks or every four weeks compared to placebo. The analysis for all primary and secondary efficacy endpoints occurred at one year.
In the ADVANCE clinical trial, PLEGRIDY met all primary and secondary endpoints by significantly reducing disease activity, including relapses and disability progression, compared to placebo, and showed favorable safety and tolerability profiles at one year. PLEGRIDY also reduced the number of new or newly enlarging T2-hyperintense lesions and the number of Gd+ lesions on brain MRI scans after one year.
After the first year, patients on placebo are re-randomized to one of the PLEGRIDY arms for the duration of the second year of the study. After completing two years in the ADVANCE study, patients have the option of enrolling in an open-label extension study called ATTAIN and will be followed for up to four years.
Through cutting-edge science and medicine,
This press release includes forward-looking statements, including
statements about the potential therapeutic effects of PLEGRIDY in MS.
These forward-looking statements may be accompanied by such words as
"anticipate," "believe," "estimate," "expect," "forecast," "intend,"
"may," "plan," "will," and other words and terms of similar meaning. You
should not place undue reliance on these statements. Drug development
and commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that unexpected concerns may arise from additional data
or analysis, regulatory authorities may require additional information
or further studies, or may fail to approve or may delay approval of our
drug candidates, or we may encounter other unexpected hurdles. For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities, please review the
Risk Factors section of our most recent annual or quarterly report filed
U.S. MEDIA CONTACT:
Ligia Del Bianco, +1 781-464-3260
EX-U.S. MEDIA CONTACT:
Biogen Idec International
Shannon Altimari, +41 41 392 16 77
Jonathan Masters, +1 781-464-2442