|Biogen'sTECFIDERA™ Confirms US Approval; Navidea Announces Enrollment of First Subject in Phase 2b Trial of NAV4694|
|By Staff and Wire Reports|
|Wednesday, 27 March 2013 19:09|
Biogen Idec (NASDAQ: BIIB) announced that the U.S. 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™ (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.
Navidea Biopharmaceuticals (NYSE: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced enrollment has commenced in its Phase 2b, open-label, safety and efficacy positron emission tomography (PET) imaging study of [18F]NAV4694 for detection of cerebral β-amyloid plaque in subjects diagnosed with Mild Cognitive Impairment (MCI). The study is designed to investigate whether NAV4694 positron emission tomography (PET) scan findings have the ability to distinguish subjects with MCI who progress to Alzheimer's disease (AD) from those who do not. Enrollment is currently planned at approximately five sites throughout the U.S. The first patient has been enrolled by the Alzheimer's Disease Center at Quincy Medical Center in Quincy, MA.
“We are pleased to participate in this important clinical study of NAV4694 aimed at evaluating a patient population in whom dementia is just emerging and for whom it is believed the best prospects for therapeutic intervention will exist,” said Dr. Anil K. Nair, MD, Chief of Neurology and Head of the Alzheimer's Disease Center at Quincy Medical Center in Quincy, MA. “Clinical trial results to date indicate that NAV4694 shows favorable sensitivity and specificity in detecting β-amyloid while exhibiting low white-matter uptake for clearer images that may assist in differential diagnoses associated with MCI. If AD could be diagnosed at an earlier stage, before clinical dementia has fully developed, the potential for successful intervention with current and future treatments could be improved considerably.”
“As the dementia field moves to earlier evaluation and treatment of cognitive impairment, it is of increasing importance to have diagnostic agents that can accurately detect the underlying cause. To our knowledge this is the first prospective, multi-center study to evaluate a radiopharmaceutical β-amyloid agent solely in subjects with MCI, an area of extreme importance as Alzheimer's disease is expected to impact as many as 14 million Americans by 2050,” commented Cornelia Reininger, MD, PhD, Navidea's Senior Vice President and Chief Medical Officer. “The outcome of this trial may enable accurate differentiation of MCI subjects who are at risk of developing Alzheimer's disease from those who are not before the disease has reached more advanced stages that can impair activities of daily living. Our ultimate goal is to provide an improved diagnostic tool with outstanding performance characteristics for physicians to aid in the diagnosis of Alzheimer's disease and other forms of neurodegenerative dementia.”
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