Multiple Sclerosis

NDA for Novel Relapsing Multiple Sclerosis Oral Treatment Submitted

By December 17, 2018

Alkermes has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for a novel oral fumarate in development to treat relapsing forms of multiple sclerosis (MS).

FDA: MS Drug Linked to Cases of Stroke, Blood Vessel Wall Tears

By November 29, 2018

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.

Ocrelizumab May Help Preserve Hand, Arm Function in PPMS

November 26, 2018

Ocrelizumab reduces risk for more severe progression

FDA: Risk of Severe Increase in Disability Following MS Treatment Discontinuation

By November 21, 2018

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.

Many Patients Do Not Engage Health Care Provider During MS Relapse

November 15, 2018

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.

Ocrevus Labeling Updated With New Info on Timing of Vaccine Administration

By November 15, 2018

According to a Phase 3b open-label study, Ocrevus may interfere with the effectiveness of non-live vaccines.

Cannabinoids Mildly Effective for Treating MS Symptoms in Adults

October 15, 2018

Review shows limited effectiveness for aiding spasticity, pain, bladder dysfunction

Fingolimod Compared With Glatiramer Acetate in Head-to-Head MS Study

By October 11, 2018

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.

FDA to Review Siponimod for Secondary Progressive Multiple Sclerosis

By October 10, 2018

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.

Psychiatric Adverse Effects of Disease-Modifying Therapies Assessed in MS Patients

By September 25, 2018

The primary outcome measure of the study was the frequency of any adverse psychiatric effect observed during treatment with one of these agents.

Fingolimod shows superior efficacy to interferon beta-1a in pediatric MS

September 21, 2018

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.

Fingolimod Cuts Multiple Sclerosis Relapses in Pediatric Patients

September 13, 2018

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.

Ibudilast Appears to Slow Brain Atrophy Progression in MS

August 31, 2018

"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.

FDA Accepts NDA Resubmission for Oral Cladribine in Relapsing MS

By July 30, 2018

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 Higher Risk of Autoimmune Disorders After HPV4 Vaccination

July 30, 2018

No significant risks were seen in exploratory analyses of individual autoimmune disorders, including Bell's palsy, optic neuritis, and Graves' disease.

FDA Approves First MS Treatment for Pediatric Patients

By May 14, 2018

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.

AAN: New Guideline on Disease-Modifying Therapies for MS Published

By April 24, 2018

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 Reduces Risk of Disability Progression in Secondary Progressive MS

By March 23, 2018

Siponimod is an investigational, selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor.

DMT Discontinuation in Older MS Patients: Clinical Outcomes Examined

By March 21, 2018

Of the total patients, 178 (29.7%) discontinued DMT during the study period with only 1 documented relapse occurring in the discontinuers.

Higher Sun Exposure Tied to Lower Risk of Multiple Sclerosis

March 08, 2018

Findings based on sun exposure at 5 to 15 years of age and at 5 to 15 years before MS onset

Multiple Sclerosis Drug Being Pulled from the Market

By March 02, 2018

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.

New Strength of Glatopa Available for Relapsing MS

By February 13, 2018

Sandoz GlatopaCare will offer a $0 co-pay support program to qualified patients.

Fetal Risk After Pregnancy Exposure to Natalizumab Examined

February 08, 2018

And, natalizumab washout period is only predictor of relapse occurrence during pregnancy

Rituximab associated with lower drug discontinuation and disease relapse rates in multiple sclerosis

January 10, 2018

Rituximab was associated with lower discontinuation rates as compared to other disease-modifying treatments in newly diagnosed patients with relapsing-remitting multiple sclerosis.

First-Line Disease-Modifying Txs Compared for Relapsing-Remitting MS

January 09, 2018

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.

Fingolimod Gets Breakthrough Therapy Designation for Pediatric MS

By December 18, 2017

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).

Do Certain Medications Increase the Risk of MS Development?

By December 07, 2017

No drug treatments were conclusively associated with an increased risk of MS.

Diet Quality May Affect MS Disability Severity

December 07, 2017

The researchers found that having dietary quality scores in the highest versus the lowest quintile correlated with lower levels of disability.

Percutaneous Transluminal Angioplasty Examined in MS Patients

November 27, 2017

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).

Positive Results for Fingolimod in Pediatric Patients With Relapsing MS

By October 30, 2017

Children and adolescents with relapsing MS had an 82% lower relapse rate with fingolimod vs. interferon beta-1a