New analysis shows fingolimod delays progression of MS disability
Fingolimod (Gilenya, Novartis) reduced the risk of disability progression in patients with relapsing-remitting multiple sclerosis, regardless of treatment history, according to a phase 3, 2-year study reported at the 63rd annual meeting of the American Academy of Neurology.
Fingolimod (Gilenya, Novartis) reduced the risk of disability progression in patients with relapsing-remitting multiple sclerosis (RRMS), regardless of treatment history, according to a phase 3, 2-year study reported at the 63rd annual meeting of the American Academy of Neurology (AAN).
The FREEDOMS analysis showed that patients new to therapy (n=493) who were treated with 0.5 mg fingolimod had a 37% reduction in the risk of 3-month confirmed disability progression compared with placebo (HR=0.63; 95% CI, 0.41–0.95). In patients previously treated with alternate therapies (n=350), fingolimod 0.5 mg led to a 30% reduction in risk (HR=0.70; 95% CI, 0.43–1.14). Consistent favorable effects on disability progression were observed for fingolimod-treated patients compared to placebo for subgroups defined by age, gender, disease severity as defined by EDSS score, relapse activity prior to study, magnetic resonance imaging lesion burden, or lesion activity at the time of the start of the study.
The primary end point for the 2-year FREEDOMS study was relapse rate, in which fingolimod reduced relapses by 54% compared with placebo (P<.001). In a key secondary end point, fingolimod showed a 30% reduction (P<.05) in the risk of 3-month confirmed disability progression as compared with placebo over 2 years.
"These data provide deeper insights into the effect of Gilenya in significantly reducing MS disability progression across the broad range of patient subpopulations that this analysis evaluated," said Virginia Devonshire, MD, director of the University of British Columbia MS Clinic and a FREEDOMS trial investigator.
FDA and EMA Accepts Applications for New Nusinersen Regimen
January 23rd 2025An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower FDA-approved dosage.
Read More
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
Listen
Trump Impact on Medicare Drug Price Negotiations Uncertain
Published: January 22nd 2025 | Updated: January 22nd 2025Trump has reversed some of President Biden’s initiatives, including $2 monthly out-of-pocket cap on some generics and experimental pricing models for gene therapies. But so far the healthcare elements of the Inflation Reduction Act remain unchanged.
Read More
