A randomized, placebo-controlled trial called REFLEX showed that 62% and 76% of patients assigned to 44 mcg of interferon subcutaneously three times or once weekly, respectively, met 2005 McDonald criteria for MS after two years – the study’s primary endpoint – compared with 86% of patients treated with placebo, said Mark Freedman, MD, of the University of Ottawa.

The differences between the two interferon dosing schedules, and between the interferon schedules and placebo, were all statistically significant (P<0.01), he told attendees at the annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC).

The treatment, glatiramer acetate, marketed as Copaxone, was tested in 16 countries among 481 patients with a telltale lesion in the central nervous system called clinically isolated syndrome.

The volunteers either received the drug or a dummy lookalike for up to three years.

Copaxone reduced the risk of developing “clinically definite” MS by 45 percent compared with a placebo.

In addition, the time it took for 25 percent of patients to develop the full-scale disease was more than doubled in the Copaxone group, at just under two years on average compared with just under one year in the placebo group.

Around a million people around the world are affected by MS, a degenerative disease in which the immune system attacks myeline, the fatty sheath that protects nerve fibres.

As a result, signals between nerve cells are delayed, disrupted or even blocked, rather like a poor connection in an electrical wire.

This causes worsening problems in coordination and balance, as well as blurred vision and slurred speech.

“This study establishes glatiramer acetate as an option for patients with clinically isolated syndrome who choose to start treatment early to improve control of the underlying disease process,” says the new paper.

The study was led by Giancarlo Comi, a professor of neurology at Milan’s Vita-Salute University in Italy.

Copaxone is currently approved for treating “relapsing-remitting” forms of MS.

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Biogen Idec (NASDAQ: BIIB) announced data results from the CHAMPIONS (Controlled High-Risk AVONEX® (interferon beta-1a) Multiple Sclerosis (MS) Prevention Study In Ongoing Neurologic Surveillance) study, an open label follow-up to CHAMPS (Controlled High Risk Subjects AVONEX MS Prevention Study). Based on the CHAMPS study, AVONEX was granted approval for use in patients who experienced their first clinical MS episode with MRI findings. The CHAMPIONS ten-year follow up showed that patients treated immediately after their first episode had significantly less chance of experiencing a second attack versus those patients with delayed treatment. These results at ten years also indicate that 80 percent of patients taking AVONEX were below an expanded disability status scale (EDSS) score of three. These data were presented as a poster at the Annual American Academy of Neurology (AAN) meeting.

“There is a consensus among physicians that early initiation of effective therapy beginning shortly after symptom onset may be required to alter the long term course of MS, but until now there has been little evidence to support this hypothesis,” said Dr. R. Philip Kinkel, director of the multiple sclerosis center, Beth Israel Deaconess Medical Center in Boston, MA and lead investigator of CHAMPIONS. “This data confirms that treatment of high risk patients beginning shortly after symptom-onset reduces relapse rates and may reduce disease progression for up to 10 years. This may translate into an ability to remain active and enjoy daily activities that otherwise might be lost without treatment.”

The CHAMPIONS open label follow-up study was designed to determine long-term clinical outcomes and the ten-year follow up included 155 patients from 24 of the 50 Phase III CHAMPS study sites. Key findings include:

– 40 percent reduction in conversion to CDMS in patients treated immediately upon diagnosis of CIS versus those that were delayed by a median of 30 months (original placebo randomization arm)

– 91 percent of patients had an EDSS less than 4.0 after 10 years;

– 80 percent of patients on AVONEX had an EDSS of less than 3; and

– the annualized relapse rate for patients with up to 10 years of care was only 0.25, suggesting a relapse rate of only one relapse every four years

“The CHAMPIONS study adds to the long-term follow-up data available and supports the benefits of starting early and staying on treatment with AVONEX,” said Thorsten Eickenhorst, M.D., vice president of global medical affairs, Biogen Idec. “This follow-up study conducted in MS patients who received early treatment reinforces the clinical effectiveness of AVONEX in patients who experience their first clinical MS episode.”

View full article here: http://www.medicalnewstoday.com/articles/156429.php

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for COPAXONE® (glatiramer acetate injection) to include the treatment of patients who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with multiple sclerosis (MS).

The FDA’s approval follows a similar decision by the Medicines and Healthcare Products Regulatory Agency (MHRA) in February 2009 under which 24 EU member states have mutually recognized an expanded label for COPAXONE® to include the treatment of patients with clinically isolated syndrome (CIS) suggestive of MS.

Up to 85% of MS patients initially experience a single neurological event suggestive of MS, known as CIS, and it has been demonstrated that early treatment initiation delays conversion from CIS to clinically definite MS (CDMS). This expanded indication in the U.S. and Europe allows patients to begin treatment with COPAXONE® from the very early stages of the disease.

“COPAXONE®, the world’s leading MS disease modifying therapy, has demonstrated the ability to provide treatment benefits very early on, when patients present with a first clinical episode and have MRI features consistent with MS,” said Moshe Manor, Teva’s Vice President, Global Branded Products, “This milestone, along with the existing long-term safety and efficacy data, further position COPAXONE® as a cornerstone in MS treatment.”

The FDA granted approval after reviewing the results of the PreCISe study, which indicated time to development of a second exacerbation was significantly delayed in patients treated with COPAXONE® compared to placebo (Hazard Ratio = 0.55; 95% Confidence Interval 0.40 to 0.77; p=0.0005). The cumulative probability of developing the second attack during the three year study period was significantly lower in the COPAXONE® group versus the placebo group (24.7% vs. 42.9%).

COPAXONE® is the only RRMS treatment with prospective long-term data demonstrating 8 out of 10 patients adhering to therapy are still able to walk unassisted after 15 years of therapy and 22 years of disease duration.

An approval for an expanded label for COPAXONE® was also granted by the Australian Health Authority (Therapeutic Goods Administration, TGA) in December 2008.

About the PreCISe Study

The multinational, multi-center, prospective, double-blind, randomized, Phase III PreCISe study was conducted globally at 80 centers. It included a total of 481 patients presenting with a single clinical episode and MRI scans suggestive of MS over a period of up to three years. Patients included were those who had a unifocal disease manifestation (i.e., clinical evidence of a single lesion). Patients received either COPAXONE® 20mg/day or placebo as a subcutaneous injection and continued treatment for up to three years, unless a second exacerbation was experienced. Patients who experienced a second exacerbation continued the trial on active treatment for an additional two years. The primary efficacy outcome was time to development of second exacerbation.

COPAXONE® (glatiramer acetate injection) was also shown to be well tolerated in the PreCISe study, with 84 percent of patients completing the three-year study period; this supports the safety and tolerability seen in RRMS patients treated with COPAXONE®.

A pre-planned interim analysis was performed on data accumulated from 81 percent of the three-year placebo-controlled study exposure. The PreCISe study demonstrated that the 25th percentile of number of days to second exacerbation more than doubled by COPAXONE® from 336 days to 722 days (Hazard Ratio = 0.55; 95% Confidence Interval 0.40 to 0.77) compared with placebo.

Moreover, there was a significant reduction in the number of new T2 lesions and in the number of T1-enhancing lesions in the COPAXONE® arm compared to the placebo arm, both at year one and year two magnetic resonance imaging (MRI) scans.

About COPAXONE®

COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE® is now approved in 51 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.

See additional important information at http://www.copaxone.com/pi/index.html

About Teva

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world’s leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva’s sales are in North America and Europe.

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