A list of the top-ten FDA-approved drugs for patients with multiple sclerosis was compiled by Genetic Engineering & Biotechnology News according to sales in 2013. Coming in at number one with $4.328 billion was Copaxone, which is approved for patients with relapse-remitting multiple sclerosis, the most common form of the disease. Copaxone (glatiramer acetate) was developed by Teva and is an immunomodulator that prevents hyperactive immune cells from attacking neurological cells and nerves in the brain and spinal cord by acting as a decoy for the myelin sheath. It is a preferred treatment, and a more concentrated three-times-per-week formulation received FDA approval earlier this month.
Not far behind, with a 2013 market share of $3 billion, is Avonex from Biogen Idec. Although it, too, is indicated to treat relapse-remitting multiple sclerosis, there is some evidence that Avonex may help to slow the progression of secondary-progressive multiple sclerosis. The recommended treatment regimen involves a gradual increase in dose from 7.5 mcg each week to 30 mcg each week in order to ameliorate flu-like symptoms that may occur with full 30 mcg at the start of therapy.
Still within the billion-dollar range are Gilenya from Novartis and Tysabri from Biogen Idec. Although they are very different therapeutic agents, Gilenya and Tysabri exert their therapeutic benefits by blocking receptors on the surface of specific subsets of leukocytes. These drugs also treat the relapse-remitting form of multiple sclerosis, but Tysabri is currently being studied for efficacy in patients with the secondary-progressive form and showed positive results from the phase II stage of trials. The drugs bring in shares of $1.9 billion and $1.67 billion, respectively.
Next, at number 5, is Betaseron from Bayer HealthCare, with $1.05 billion in sales (figure reported in September 2013). It is not completely understood how Betaseron (interferon beta-1b) works, but it is thought to have benefit for relapse-remitting multiple sclerosis patients by preventing T cells from further destroying the myelin sheath around axons. The two-year BENEFIT study found that Betaseron significantly delays the time to a second flare-up in patients with clinically isolated syndrome.
Below the billion-dollar mark, but still of considerable notice, are Tecfidera (Biogen Idec, $876 million), Rebif (EMD Serono and Pfizer, $622 million), Ampyra (Acorda Therapeutics and Biogen Idec, $302.301 million), Aubagio (Genzyme, $226 million), and Extavia (Novartis, $159 million). Each is indicated for relapse-remitting multiple sclerosis, with Ampyra being indicated to improve walking in patients with multiple sclerosis and not to actually modify the disease. Certainly, these drugs have improved the lives of countless patients with multiple sclerosis and their families, but there is a noticeable lack of treatments approved for secondary-progressive multiple sclerosis. Though some of the top-ten drugs are being investigated for benefit in the secondary-progressive form, other trials persist to find help for these patients with more aggressive degeneration of the nervous system.
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