Tag: Gilenya


New MS Research into cytokine regulation, neuroprotection, tolerance induction


Evotec AG, a German company specializing in the provision of drug discovery resources to biotech companies and learning institutions, announced that is going to begin three new research projects for the treatment of multiple sclerosis (MS), which will be supported by funds from the German Federal Ministry of Education and Research....

SMC first to introduce oral Gilenya® as a first line treatment option for people with a severe form of MS


• Scottish people with a severe form of relapsing remitting multiple sclerosis are first in UK to get access to once daily pill fingolimod as a first line treatment option1
• Once daily pill fingolimod reduces the risk of relapses by 67% compared to placebo

Today, the Scottish Medicines Consortium (SMC) has accepted once daily pill fingolimod (Gilenya®) as a first line option for people with a severe form of relapsing remitting MS, which has been shown to reduce the risk of relapses by 67% compared to placebo.1,2 This is the first time that an oral treatment has been made available as a first line treatment option for people with this severe form of MS - known as rapidly evolving severe relapsing remitting MS (RES RRMS).....

Thousands of people possibly wrongly diagnosed with Multiple Sclerosis, experts warn


The National Institute for Health and Care Excellence has changed guidelines for Multiple Sclerosis.

Thousands of people may be being wrongly diagnosed with Multiple Sclerosis or not diagnosed at all, health experts have warned as they changed guidelines to improve detection of the condition.
The National Institute for Health and Care Excellence said that as many as one in 10 cases was misdiagnosed and called for more thorough scans and tests to be carried out....

Evotec and its partners awarded public grants to develop new MS drug candidates


Evotec AG announced today that it has entered into three novel research projects for the treatment of Multiple Sclerosis supported by research funds from the German Federal Ministry of Education and Research.

The respective scientific approaches stem from the Deutsches Rheuma-Forschungszentrum; an institute of the Leibniz Association; Prof. A. Hamann and the University Medical Center Hamburg-Eppendorf; Prof. M. Friese; Dr J. Herkel comprising cytokine regulation, neuroprotection and tolerance induction..

Early treatment with Teriflunomide may slow MS development


Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial.

Miller AE, Wolinsky JS, Kappos L, Comi G, Freedman MS, Olsson TP, Bauer D, Benamor M, Truffinet P, O'Connor PW; TOPIC Study Group.

Abstract

BACKGROUND: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting multiple sclerosis. We aimed to assess the efficacy and safety of teriflunomide in patients with a first clinical episode suggestive of multiple sclerosis.

METHODS: In this randomised, double-blind, placebo-controlled, parallel-group study, we enrolled patients aged 18-55 years with clinically isolated syndrome (defined as a neurological event consistent with demyelination, starting within 90 days of randomisation, and two or more T2-weighted MRI lesions ≥3 mm in diameter) from 112 centres (mostly hospitals) in 20 countries. Participants were randomly assigned (1:1:1) in a double-blind manner (by an interactive voice response system) to once-daily oral teriflunomide 14 mg, teriflunomide 7 mg, or placebo, for up to 108 weeks. Patients, staff administering the interventions, and outcome assessors were masked to treatment assignment. The primary endpoint was time to relapse (a new neurological abnormality separated by ≥30 days from a preceding clinical event, present for ≥24 h in the absence of fever or known infection), which defined conversion to clinically definite multiple sclerosis. The key secondary endpoint was time to relapse or new gadolinium-enhancing or T2 lesions on MRI, whichever occurred first. The primary outcome was analysed for the modified intention-to-treat population; safety analyses included all randomised patients who were exposed to the study drug, as treated. This trial is registered with ClinicalTrials.gov, number NCT00622700.

FINDINGS: Between Feb 13, 2008, and Aug 22, 2012, 618 patients were enrolled and randomly assigned to teriflunomide 14 mg (n=216), teriflunomide 7 mg (n=205), or placebo (n=197). Two patients in each of the teriflunomide groups did not receive the study drug, so the modified intention-to-treat population comprised 214 patients in the teriflunomide 14 mg group, 203 in the teriflunomide 7 mg group, and 197 in the placebo group. Compared with placebo, teriflunomide significantly reduced the risk of relapse defining clinically definite multiple sclerosis at the 14 mg dose (hazard ratio HR 0·574 95% CI 0·379-0·869; p=0·0087) and at the 7 mg dose (0·628 0·416-0·949; p=0·0271). Teriflunomide reduced the risk of relapse or a new MRI lesion compared with placebo at the 14 mg dose (HR 0·651 95% CI 0·515-0·822; p=0·0003) and at the 7 mg dose (0·686 0·540-0·871; p=0·0020). During the study, six patients who were randomly assigned to placebo accidently also received teriflunomide at some point: four received 7 mg and two received 14 mg. Therefore, the safety population comprised 216 patients on teriflunomide 14 mg, 207 on teriflunomide 7 mg, and 191 on placebo. Adverse events that occurred in at least 10% of patients in either teriflunomide group and with an incidence that was at least 2% higher than that with placebo were increased alanine aminotransferase (40 19% of 216 patients in the 14 mg group, 36 17% of 207 in the 7 mg group vs 27 14% of 191 in the placebo group), hair thinning (25 12% and 12 6% vs 15 8%), diarrhoea (23 11% and 28 14% vs 12 6%), paraesthesia (22 10% and 11 5% vs 10 5%), and upper respiratory tract infection (20 9% and 23 11% vs 14 7%). The most common serious adverse event was an increase in alanine aminotransferase (four 2% and five 2% vs three 2%).

INTERPRETATION: TOPIC is to our knowledge the first study to report benefits of an available oral disease-modifying therapy in patients with early multiple sclerosis. These results extend the stages of multiple sclerosis in which teriflunomide shows a beneficial effect.

FUNDING: Genzyme, a Sanofi company.

Source: Lancet Neurol. 2014 Oct;13(10):977-86. doi: 10.1016/S1474-4422(14)70191-7. Epub 2014 Sep 2.& Pubmed PMID: 25192851 © 2014 Elsevier Ltd (23/09/14) http://www.ms-uk.org/aubagio

No cognitive disadvantage in paediatric- vs adult-onset MS


A new study suggests no cognitive disadvantage in the long term for patients with multiple sclerosis (MS) that began in childhood vs those with adult-onset disease.

Researchers are reporting that overall, cognitive outcomes were similar between the groups and that there were actually fewer patients in the pediatric-onset group, matched with adult-onset patients for age and education, who were classified as cognitively impaired. However, the difference between groups was not statistically significant...

The Scottish Medicines Consortium approves Aubagio® (teriflunomide) for use in MS


New oral treatment can be offered as an alternative to currently available injectable treatment options...

Gilenya appears to have an effect on B-Cells in MS


Differential effects of fingolimod on B-cell populations in multiple sclerosis....

MS drug Aubagio wins final approval from NICE


Sanofi’s multiple sclerosis drug Aubagio won final approval from the U.K.’s health-cost agency, allowing access to a market in which it will compete with Novartis AG’s Gilenya.

The National Institute for Health and Care Excellence, or NICE, recommended Aubagio, also known as teriflunomide, as a treatment option for adults with relapsing-remitting multiple sclerosis, the most common form of the disease, it said in a statement today. The decision confirms a preliminary ruling made last month in which NICE recommended the drug after Paris-based Sanofi agreed to a price cut.........

Teriflunomide in multiple sclerosis: Added benefit not proven


Teriflunomide (trade name: Aubagio) has been approved in Germany since August 2013 for adults with relapsing remitting multiple sclerosis. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this new drug offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA).......
Return to Top ▲Return to Top ▲