Get $200 with your 1st order. Same day blood tests, next day results. Google reviews

Private MD News

Home | News | Autoimmune Diseases

Review date of multiple sclerosis drug pushed back

Category: Autoimmune Diseases

Reuters has reported that a new drug, BG-12, which will be used to treat multiple sclerosis (MS), will have its review from the U.S. Food and Drug Administration (FDA), pushed back by three months.

BG-12, or dimethyl fumarate, which was developed by biotechnology company, Biogen Idec Inc. will be the second oral MS drug available. According to Science News Magazine, clinical trials have shown that BG-12 significantly increases the time between relapses of the disease's symptoms, which include impaired muscle control, balance, vision and speech.

The positive results of the drug, along with the lack of safety concerns, have prompted Biogen Idec Inc's stock to rise 50 percent over the last year, Reuters notes. The recent setbacks caused a 2 percent decrease in the stock's value, bringing it to $150.72 as of the morning trading period on Oct. 18.

According to the news source, there will be no more studies required by the FDA, but more time is needed to review the application. Analysts claim that this is not uncommon, especially with the large amount of patients involved in the registrational studies. Both DEFINE and CONFIRM test, looked at BG-12's effectiveness for warding off the effects of MS compared to a placebo.

"The registrational studies for BG-12 - DEFINE and CONFIRM - enrolled about 1,200 and 1,400 patients, respectively" said Barclays Capital analyst Anothony Butler to Reuters. "Given the size and complexity of the filings, we are not surprised that the FDA would require additional time to review the application."

Reuters also reported that analysts predict BG-12's sales will hit $390 million in 2013 and rise to $980 million the following year. The drug is presently undergoing regulatory review in the European Union, Australia and Canada.

Multiple sclerosis symptoms
According to the National Institutes of Health (NIH), MS is an autoimmune disease that impacts the brain and central nervous system by damaging the the protective layer around nerve cells known as the myelin sheath. The sheath is involved with the delivery process of the nerve signals, and when it's damaged, the signals are slowed or stopped.

The NIH reports that inflammation is the culprit when it comes to the nerve damage, which is the result of the immune system attacking the central nervous system, and it can occur not only in the spinal cord and brain, but also in the optic nerve.

Diagnosis
MS is usually diagnosed by ruling out certain ailments, such as other infectious or inflammatory diseases and viral infections that have similar symptoms, which are detected with spinal taps and blood testing. MRIs can also reveal lesions, which are signifiers of a depleted myelin sheath on the brain or spinal cord.

Related Articles from Private MD:

News Categories:

Advanced Lipid Treatment I   Allergy Testing   Anemia and RBC disorders   Autoimmune Diseases   Bariatric Lab Testing   Blood and Blood Diseases   Breast   Cancer Detection and Tumor Markers   Celiac Disease Testing   Chlamydia   Coagulation and blood clotting disorders   Colon   DNA, Paternity and Genetic testing   Diabetes   Drug Screening   Environmental Toxin Testing   Female Specific Tests   Gastrointestinal Diseases   General Health   General Wellness   HIV   HIV monitoring/Treatment/Testing/Post Diagnos   Heart Health and Cholesterol   Herpes   Hormones and Metabolism   Infectious Diseases   Infertility Testing-Male   Infertitlity Hormone Testing   Kidney Diseases   Leukemia and WBC disorders   Liver   Liver Diseases   Lyme Disease   Male Specific Tests   Menopause/Peri-Menopausal Diagnosis   Musculoskeletal Diseases   Nicotine Screening   Organ Specific Testing   Ovarian   Prostate   Prostate   Sexually Transmitted Diseases   Thyroid Diseases   Transgender Hormone Testing-Male to Female   Transgender Hormone Testing-female to male   Vitamin D Deficiency-Diagnosis and Treatment   

Visit the Health News Archive: Click Here

Questions about online blood testing or how to order a lab test?

Speak with our Wellness Team: (877) 283-7882
Back to top