According to a new study, magnetic resonance imaging (MRI) measurements of atrophy in an important area of the brain are an accurate predictor of multiple sclerosis (MS).

The study was published online in the journal Radiology. Researchers found that these atrophy measurements provide an improvement in assessing patients at risk for MS.

A definitive diagnosis of MS involves a combination of factors including medical history, neurological exams, development of a second clinical attack, and detection of new and enlarging lesions with contrast-enhanced or T2-weighted MRI. Visual disturbances, muscle weakness and trouble with coordination and balance are symptoms of the disease, which develops as the body’s immune system attacks and damages the myelin. Myelin is the protective layer of fatty tissue that surrounds nerve cells within the brain and spinal cord.

“For some time we’ve been trying to understand MRI biomarkers that predict MS development from the first onset of the disease,” Robert Zivadinov, MD, PhD, FAAN, Buffalo Neuroimaging Analysis Center of the University at Buffalo in Buffalo, NY said. “In the last couple of years, research has become much more focused on the thalamus.”

Thalamus is a structure of matter deep within the brain which acts like a relay center for nervous impulses. Zivadinov said that thalamic atrophy could change the way MS is looked at and how to develop drugs to treat the disease. The research team looked investigated the association between the development of thalamic atrophy and conversion to clinically definite MS.

“One of the most important reasons for the study was to understand which regions of the brain are most predictive of a second clinical attack,” Zivadinov stated. “No one has really looked at this over the long term in a clinical trial.”

Contrast-enhanced MRI was used to asses 216 CIS patients. Follow-up scans were performed at six months, one year, and two years. They found that over two years, 92 patients, or 42.6 percent, converted to clinically definite MS. Decreases in thalamic volume and increases in lateral ventricle volumes were the MRI measures that were independently associated with the development of clinically definite MS. Results showed that atrophy of the thalamus is associated with MS and also that thalamic atrophy is a better predictor of clinically definite MS than accumulation of T2-weighted and contrast-enhanced lesions. Findings suggest measurement of thalamic atrophy and increase in ventricular size may help identify patients at high risk.

“Thalamic atrophy is an ideal MRI biomarker because it’s detectable at very early stage,” Dr. Zivadinov commented. “It has a very good predictive value, and you will see it used more and more in the future.”

The study group is still being followed by the research team, which plans to publish results from the four-year follow-up in summer of 2014.

Source: "Thalamic Atrophy is Associated with Development of Clinically Definite Multiple Sclerosis." Collaborating with Dr. Zivadinov were Eva Havrdová, M.D., Ph.D., Niels Bergsland, M.S., Michaela Tyblova, M.D., Jesper Hagemeier, M.S., Zdenek Seidl, M.D., Ph.D., Michael G. Dwyer, M.S., Manuela Vaneckova, M.D., Ph.D., Jan Krasensky, M.Sc., Ellen Carl, Ph.D., Tomas Kalincik, M.D., Ph.D., Dana Horáková, M.D., Ph.D.

Last Updated: 4/25/13; 3:20PM EST

Biogen Idec announced that its multiple sclerosis drug, TECFIDERA, received US Food and Drug Administration (FDA) approval for first-line oral treatment for people with relapsing forms of the disease.

According to the company, Biogen will make this oral capsule available in the US to people living with multiple sclerosis (MS).

The drug has been clinically proved to significantly reduce relapses and development of brain lesions, as well as to slow disability progression over time. It also has demonstrated a favorable safety and tolerability profile.

“With the FDA approval of TECFIDERA, we will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill – a combination we believe will have significant positive impact on the way people live with this chronic disease,” said George A. Scangos, PhD, Chief Executive Officer of Biogen Idec said in a statement. “Biogen Idec is committed to delivering innovative treatments and setting new standards for the next generation of medicines. We believe TECFIDERA will raise expectations for what people living with MS can achieve with their therapy.”

The approval of the drug is based on two Phase III studies, DEFINE and CONFIRM, as well as an ongoing extension study, ENDORSE.

“In clinical trials, patients with dimethyl fumarate had less disease activity when compared to patients on placebo – whether they were in early stages of MS or had more established disease,” Robert Fox, MD, Medical Director of the Mellen Center for Multiple Sclerosis at Cleveland Clinic, lead investigator of the CONFIRM study, and a paid advisor for Biogen Idec projects not related to TECFIDERA clinical development stated. “With the efficacy, safety and tolerability measures seen in CONFIRM, this drug provides physicians with an important additional treatment option for their patients across the MS spectrum.”

Source: Biogen Idec

Last Updated: 3/27/13; 5:25PM EST

Genzyme, a Sanofi Company, recently announced that the Committee for Medicinal Products of Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the company’s Aubagio. The recommendation is for the approval of the once-daily, oral Aubagio (teriflunomide) for treatment of adult patients with relapsing-remitting multiple sclerosis (MS).

“The fact that Aubagio has demonstrated a positive effect on disability progression in two, phase III clinical studies underscores its importance as a new treatment option for relapsing-remitting MS patients,” Professor Ludwig Kappos, MD, Chair of Neurology, University Hospital, Basel, Switzerland said in a statement.

Aubagio is an immunomodulator with anti-inflammatory properties. The drug is already approved in the United States and Australia for relapsing MS. In Europe there are roughly 630,000 people affected by MS.

“This positive CHMP opinion and broad recommended indication reflect the strong data from Aubagio’s clinical development program. As we’ve seen from the uptake of Aubagio in the United States, many patients are looking for an alternative to current injectable therapies,” Genzyme’s CEO and President, David Meeker, MD, stated.

Although the CHMP recommended Abuagio for treatment of relapsing-remitting MS, the CHMP did not recommend Aubagio receive a new active substance (NAS) designation.

“We are very disappointed about the CHMP opinion regarding new active substance designation. We believe based on the product’s characteristics and current data that Aubagio is a new active substance,” Meeker said. “Aubagio has been studied for over 10 years in one of the largest and broadest clinical development programs of any MS therapy. This decision could have a detrimental impact on future scientific innovation in MS and other diseases. We are considering all options and planning to request a re-examination of the new active substance designation.”

Source: Genzyme

Last Updated: 3/26/13; 3:15PM EST

Biogen Idec recently announced that the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) has provided a positive opinion recommending a marketing authorization be granted for the company’s multiple sclerosis drug.

The recommendation is for Tecfidera (dimethyl fumarate) as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). The CHMP considers there to be a favorable benefit-to-risk balance for the drug based on quality, safety and efficacy data submitted by Biogen. The recommendation by CHMP is now referred to the European Commission which determines whether or not the medicine should receive marketing authorization in the European Union. Additionally, Tecfidera should receive a decision from the US Food and Drug Administration (FDA) on its marketing application shortly.

“With the CHMP’s positive opinion for Tecfidera, we are one step closer to offering the European MS community a treatment with compelling efficacy and a favorable safety profile in the convenience of a pill – a combination we believe will have a significant positive impact on the way people live with this chronic disease,” George A. Scangos, PhD, Chief Executive Officer of Biogen Idec stated. “Biogen Idec is committed to delivering innovative treatments and setting new standards for the next generation of medicines. We believe Tecfidera will raise expectations for what people living with MS can achieve with their therapy.”

The recommendation was based on data from two Phase 3 studies, DEFINE and CONFIRM, consisting of over 2,600 RRMS patients, as well as an extension study in which some patients have been followed for more than four years. In DEFINE, results showed that for patients who received Tecfidera twice-daily the proportion of patients who relapsed was reduced by 49 percent, the annualized relapse rate was reduced by 53 percent, and 12-week confirmed disability progression was reduced by 38 percent compared to placebo at two years. The CONFIRM study showed that for patients receiving Tecfidera twice-daily reduced annual relapse rate by 44 percent and the proportion of patients who relapsed by 34 percent compared to placebo at two years. Additionally, they saw a 21 percent reduction in 12-week confirmed disability progression, however this was not considered statistically significant.

“Clinical studies demonstrated Tecfidera was an effective therapy with a favorable safety profile for people with relapsing-remitting MS,” Professor Gavin Giovannoni, Chair of Neurology, Blizard Institute, Barts and The London School of Medicine and Dentistry stated. “This, combined with its interesting suggested mechanism of action, should position Tecfidera as a first-line therapy choice.”

A decision from the European Commission is expected in roughly two months.

Source: Biogen Idec

Last Updated: 3/26/13; 12:10PM EST