Cambridge, Massachusetts based Biogen Inc. has reported its second quarter 2015 results, posting a year-over-year seven percent revenue increase to $2.6 Billion in the quarter.
“Biogen remains focused on improving the lives of people living with complex diseases,” says Chief Executive Officer George A. Scangos, Ph.D. “Tecfidera, which is now the most prescribed oral MS therapy globally, is experiencing moderated patient growth following rapid initial uptake. The launch of Plegridy is expanding into new markets, and Tysabri continues to add new patients requiring higher efficacy. Additionally, our hemophilia products are being adopted by an increasing number of patients, and we are working toward the anticipated launches of our first two biosimilar candidates in Europe next year.”
Tecfidera (dimethyl fumarate, formerly known as BG-12) is Biogen’s blockbuster oral therapy for treatment of relapsing forms of Multiple Sclerosis (MS), described by Biogen as an effective, long-term treatment for people living with relapsing forms of MS. Data from two completed clinical trials and one ongoing show that Tecfidera has been proven to reduce rate of MS relapses, slow the progression of disability, and the number of MS brain lesions, while demonstrating a favorable safety and tolerability profile in a broad range of patients with relapsing forms of MS. The drug significantly reduces relapses and disability progression in newly-diagnosed relapsing-remitting MS (RRMS) patients who had highly active disease. Additional data indicate Tecfidera showed strong and sustained efficacy over five years in RRMS patients who were previously treated with an interferon (interferon beta-1a/b [IFN]) or glatiramer acetate (GA). These results were outlined on April 23 in poster presentations at the 67th American Academy of Neurology (AAN) Annual Meeting held April 18–25, 2015 at the Walter E. Washington Convention Center in Washington, DC.
“Taken together, these studies reinforce that Tecfidera delivers robust efficacy when used as a first-line therapy, as well as when it is used after a patient has discontinued interferon or glatiramer acetate treatment,” notes J. Theodore Phillips, M.D., Ph.D. , research investigator at the Baylor Institute for Immunology Research and clinical professor of Neurology at the University of Texas Southwestern Medical Center. “In addition, strong efficacy was observed with Tecfidera treatment in various patient populations including those with highly active MS.”
Tecfidera is taken orally, with or without food. The initial recommended dose of Tecfidera is 120 mg twice a day for a total of 240 mg per day for seven days. The usual dose of Tecfidera after seven days is two 240 mg capsules taken daily, for a total of 480 mg per day.
It is believed that Tecfidera provides a new approach to treating MS by activating the Nrf2 pathway, although its exact mechanism of action is unknown. The drug is thought to inhibit immune cells and molecules, and may have anti-oxidant properties that could be protective against damage to the brain and spinal cord. It is theorized that Tecfidera may work by changing the way the body’s immune system works, to help keep it from further damaging the brain and spinal cord. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS.
DEFINE, CONFIRM, and ENDORSE
The New England Journal of Medicine published results from two phase III clinical trials; DEFINE (Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting MS) and CONFIRM (Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis) for BG-12 capsules in people living with relapsing-remitting MS.
DEFINE (Determination of the Efficacy and safety of oral Fumarate IN relapsing-rEmitting MS) was a global, two-year, randomized, multi-center, double-blind, placebo-controlled, dose-comparison Phase 3 clinical trial that enrolled more than 1,200 patients with RRMS at 198 sites in 28 countries. The study evaluated Tecfidera (240 mg, BID or TID) compared to placebo.involved more than 1,200 participants and was designed to determine if BG-12 (Tecfidera) would be effective in decreasing the proportion of subjects experiencing relapses compared to that of a placebo, while also noting factors of safety and tolerability. The secondary outcomes included progression of disability, frequency of relapses and disease activity as detected by MRI.
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