Biogen Confirms US Approval for TECFIDERA
Today Biogen Idec (NASDAQ: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TECFIDERA™ (dimethyl fumarate), a new first-line oral treatment for people with relapsing forms of multiple sclerosis (MS). Biogen Idec will make this oral capsule available to people living with MS in the United States in the coming days.
Image of Biogen Idec's TECFIDERA(TM) (dimethyl fumarate) which was approved by the U.S. FDA on March 27, 2013 for relapsing multiple sclerosis. (Photo: Business Wire) TECFIDERA has been clinically proven to significantly reduce important measures of disease activity, including relapses and development of brain lesions, as well as to slow disability progression over time, while demonstrating 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 a significant positive impact on the way people live with this chronic disease,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “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 FDA approval of TECFIDERA is based on data from a robust clinical development program that included DEFINE and CONFIRM, two global Phase 3 studies that enrolled more than 2,600 patients. In the ongoing extension study, ENDORSE, some patients receiving TECFIDERA have been followed for more than four years.
In DEFINE, TECFIDERA, administered twice daily, significantly reduced the proportion of patients who relapsed by 49 percent (p<0.0001), the annualized relapse rate (ARR) by 53 percent (p<0.0001), and 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent (p=0.0050) compared to placebo at two years. In CONFIRM, twice-daily TECFIDERA significantly reduced ARR by 44 percent (p<0.0001) and the proportion of patients who relapsed by 34 percent (p=0.0020) compared to placebo at two years. While not statistically significant, TECFIDERA showed a 21 percent reduction in 12-week confirmed disability progression in CONFIRM. Both studies also showed that TECFIDERA significantly reduced lesions in the brain compared to placebo, as measured by magnetic resonance imaging (MRI).
“In clinical trials, patients treated with dimethyl fumarate had less disease activity when compared to patients on placebo – whether they were in the early stages of MS or had more established disease,” said Robert Fox, M.D., 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 for projects not related to TECFIDERA clinical development. “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.”
The most common side effects associated with TECFIDERA are flushing and gastrointestinal (GI) events (i.e., diarrhea, nausea and abdominal pain). In clinical studies, flushing symptoms usually began soon after initiating treatment, were mostly mild to moderate, and usually improved or resolved over time. The incidence of GI events was higher early in the course of treatment (primarily in the first month) and decreased over time. Overall, clinical trial discontinuations due to flushing and GI events were low.
TECFIDERA may decrease lymphocyte counts in some patients. In clinical studies, mean lymphocyte counts decreased during the first year of treatment and then remained stable. The incidence of infections and serious infections was similar in TECFIDERA-treated patients and those on placebo. There were no opportunistic infections in TECFIDERA-treated patients. In patients with low lymphocyte counts, there was no increased incidence in serious infections. Patients taking TECFIDERA should have a complete blood count (CBC) before starting treatment to measure lymphocyte counts. A follow up CBC is recommended annually and at the discretion of the treating physician.
“We are pleased to see a new, needed treatment option available to people living with MS,” said Dr. Timothy Coetzee, chief research officer at the National MS Society. “With the collaborative focus on MS research around the world, it is an exceptionally encouraging time for those who have been diagnosed with relapsing forms of MS.”
TECFIDERA marks the fourth therapy Biogen Idec offers worldwide to people living with MS.
Additional TECFIDERA Updates
On March 22, 2013 the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) issued a positive opinion recommending a marketing authorization be granted for TECFIDERA as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). The CHMP's recommendation has now been referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union. On March 19, 2013, the United States Patent and Trademark Office issued a patent covering the dosing regimen of daily administration of 480 mg of TECFIDERA. This patent will expire in 2028. The European Patent Office recently determined that Biogen Idec's application for a patent covering the dosing regimen of daily administration of 480 mg of TECFIDERA is allowable. Once granted, the EU patent would also expire in 2028. TECFIDERA is also currently under review by regulatory authorities in Australia, Canada and Switzerland.
For more information on TECFIDERA, prescribing information and financial assistance programs go to TECFIDERA.com or biogenidec.com.
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