Sine the approval of Lemtrada in 2014, the Agency has identified 13 cases worldwide of ischemic and hemorrhagic stroke or arterial dissection that occurred shortly after the patient received Lemtrada.
From September 2010 to February 2018, the FDA has identified 35 cases of severe increased disability accompanied by the presence of new lesions on MRI that occurred 2 to 24 weeks after stopping treatment with fingolimod.
The annualized relapse distribution was 44.1, 35.5, and 20.2% of patients with less than 1, 1 to 2, and more than 2 relapses, respectively.
According to a Phase 3b open-label study, Ocrevus may interfere with the effectiveness of non-live vaccines.
ASSESS (N=1064), a randomized, rater- and dose-blinded study, evaluated the safety and efficacy of once-daily Gilenya 0.25mg and 0.5mg vs once-daily subcutaneous Copaxone 20mg in patients with RRMS.
The NDA is based on data from the EXPAND study, a randomized, double-blind, placebo-controlled Phase 3 study in 1652 participants living with SPMS.
The primary outcome measure of the study was the frequency of any adverse psychiatric effect observed during treatment with one of these agents.
Among pediatric patients with relapsing multiple sclerosis, fingolimod was associated with a lower annualized rate of relapse and lower incidence of new lesions identified on T2-weighted magnetic resonance imaging (MRI) compared to interferon beta-1a.
The annualized rate of new or newly enlarged lesions on T2-weighted magnetic resonance imaging was 4.39 with fingolimod and 9.27 with interferon beta-1a.
"Further trials are needed to identify whether the effect on brain atrophy is reproducible and is associated with slowed progression of neurologic disability," the authors write.
The NDA resubmission is in response to the FDA's Complete Response Letter issued in 2011 which requested an improved understanding of the safety risks and overall benefit-risk profile.
No significant risks were seen in exploratory analyses of individual autoimmune disorders, including Bell's palsy, optic neuritis, and Graves' disease.
The FDA's decision was based on data from the Phase 3 PARADIGMS study (N=215) which evaluated the safety and efficacy of oral fingolimod vs interferon beta-1a injection in pediatric patients aged 10 to <18 years with relapsing MS.
The guideline, published in the journal Neurology, provides recommendations on initiating, switching, and discontinuing DMTs relevant to patients with relapsing-remitting MS (RRMS), secondary progressive MS, primary progressive MS (PPMS), and clinically isolated syndromes of demyelination.
Siponimod is an investigational, selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor.
Of the total patients, 178 (29.7%) discontinued DMT during the study period with only 1 documented relapse occurring in the discontinuers.
Because of its safety profile, the use of Zinbryta is generally reserved for patients who have had an inadequate response to 2 or more MS drugs.
Rituximab associated with lower drug discontinuation and disease relapse rates in multiple sclerosis
Rituximab was associated with lower discontinuation rates as compared to other disease-modifying treatments in newly diagnosed patients with relapsing-remitting multiple sclerosis.
Of the 494 patients, 43.5% received an injectable DMT, 17.4% dimethyl fumarate, 3.4% fingolimod, 10.1% natalizumab, 24.3% rituximab, and 1.2% other DMT.
The FDA has granted Breakthrough Therapy designation for fingolimod for the treatment of children and adolescents 10 years of age or older with relapsing multiple sclerosis (MS).
The researchers found that having dietary quality scores in the highest versus the lowest quintile correlated with lower levels of disability.
There was no difference in the composite functional measure (walking control, balance, manual dexterity, postvoid residual urine volume, and visual acuity) between the PTA and sham groups (41.7 vs. 48.7%; odds ratio, 0.75; 95% confidence interval, 0.34 to 1.68; P=0.49).
Children and adolescents with relapsing MS had an 82% lower relapse rate with fingolimod vs. interferon beta-1a