The regulatory applications included positive one-year results from the two-year global Phase 3 ADVANCE study. The data demonstrated that PLEGRIDY met all primary and secondary endpoints by significantly reducing disease activity including relapses, disability progression and brain lesions compared to placebo, and showed favorable safety and tolerability profiles at one year.
“We expect that interferons will remain an important and widely used
option for patients with MS. At one-year, PLEGRIDY demonstrated
significant reductions in relapses and disability progression, as well
as a robust impact on several MRI endpoints,” said
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.
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. 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 of PLEGRIDY, including the dosage and
related 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
Ligia Del Bianco, +1 781-464-3283
Carlo Tanzi, PhD, +1 781-464-2442