FDA Approved Disease Modifying Agents

For this post I will be continuing my discussion on MS and more specifically treatments that many MS patients are currently using. At present time there is no cure for MS, however several medications and therapies are being used to modify the course of the disease, treat relapses or flare-ups, manage symptoms and to improve a patients function and safety. Used in conjunction with each other medication and therapy can greatly enhance a patient’s life.


FDA Approved Disease Modifying Agents:

· Avonex: Made up of the same amino acids (the major components of proteins) as the interferon beta that is naturally present in the human body, this medication has been approved by the Federal Drug Administration (FDA) for the treatment of patients with relapsing types of MS. Avonex is manufactured by a biotechnological process from a naturally occurring interferon and works to slow the accumulation of physical disability and decrease the rate of recurrence of clinical exacerbations. In controlled clinical trials Avonex has been shown to reduce the risk of the disability progressing, decrease the amount of exacerbations experienced, and showed that the number and size of lesions in the brain were reduced.

· Betaseron: Betaseron is like Avonex in that it is manufactured by a biotechnological process from a naturally occurring interferon. Betaseron is approved by the FDA for treating relapsing types of MS to reduce the frequency of clinical exacerbations. In addition, Betaseron has been approved for patients who have experienced a first clinical episode (clinically-isolated syndrome) and have features viewable with an MRI that are consistent with having multiple sclerosis. Both Avonex and Betaseron are taken by injection; however Betaseron is taken every other day while Avonex is taken once a week.

· Copaxone: Copaxone is a synthetic protein that stimulates the basic protein of myelin; the basic protein is a part of the myelin that insulates the nerve fibers in the spinal cord and brain. Through methods not fully understood, this drug seems to act as a myelin decoy and keep the myelin-damaging T-cells from damaging the myelin. Copaxone is approved by the FDA to reduce the occurrences of relapses in patients with relapsing-remitting MS. It is also approved for use in those who have experienced a first clinical episode (clinically-isolated syndrome) and have MRI features that are consistent with multiple sclerosis. Unlike both Betaseron and Avonex, Copaxone is injected every day.

· Novantrone: Previously only used to treat certain forms of cancer, the drug, which is part of a group of medicines called antineoplastics, was approved for MS and acts to suppress the activity of both T and B cells as well as macrophages which are thought to lead the attack on the myelin sheath. Based on findings from these studies, the FDA has approved Novantrone for reducing neurologic disability and/or the frequency of clinical relapses (attacks) in patients with secondary progressive MS, progressive-relapsing MS and worsening relapsing-remitting MS. Novantrone has not been approved for the treatment of primary-progressive MS. Additionally this drug is only used once every three months with a maximum of 8 to 12 doses total.

· Rebif: Like both Betaseron and Avonex, Rebif is a medication that is manufactured by a biotechnological process from one of the naturally-occurring Interferons. Rebif is injected as well however only 3 times a week. Rebif is approved for the treatment of patients who have relapsing forms of MS to diminish the frequency of clinical exacerbations and delay the accumulation of physical disability. The FDA has stated that “Patients treated with Rebif 44 mcg [micrograms] sc [delivered subcutaneously] tiw [3 times per week] were more likely to remain relapse-free at 24 and 48 weeks than were patients treated with Avonex 30 mcg im [delivered intramuscularly] qw [once per week].”

· Tysabri: Tysabri is a monoclonal antibody that is produced in a laboratory, its purpose is to hamper the movement of immune cells, that could be potentially damaging, that are in the bloodstream from reaching across the “blood-brain barrier” in to the brain and spinal cord. Tysabri has been approved by the FDA as a monotherapy (not to be used in combination with another disease-modifying therapy) for the treatment of patients who have been diagnosed with relapsing forms of MS to delay the addition of physical disability and reduce the occurrence of clinical exacerbations. Because Tysabri increases the risk of progressive multifocal leukoencephalopathy it is recommended primarily for patients who have not responded well, or cannot take, an alternative treatment. Unlike any of the other treatments, Tysabri is giving by intravenous infusion once every 4 weeks.



These are just part of a larger plan of action when it comes to living with and treating MS. There are many other aspects of treatment that together make up a strategic treatment plan that works to bring a better quality of life to those living with MS. I am currently taking Betaseron which I inject every other day. After first beginning the injections I did experience flu-like symptoms which are somewhat common. However, as time went by the symptoms faded and now that I am taking a full dose I am experiencing no apparent side effects. I do not know how the medication is working or whether it is doing its job or not, some of my symptoms have faded somewhat, some have gone away and came back and some have gotten worse. I guess only time will tell.

I will be continuing this post with more information on treatments used for MS, including how alternative medicines can play a role in treating MS and the political news that may finally bring a cure to those living with MS.


Jamie