Current Treatments
BETASERON® (interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis

AVONEX® (Interferon beta-1a) is a 166 amino acid glycoprotein with a predicted molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of AVONEX® is identical to that of natural human interferon beta.

COPAXONE is the brand name for glatiramer acetate (formerly known as copolymer-1). Glatiramer acetate, the active ingredient of COPAXONE, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000 – 9,000 daltons. Glatiramer acetate is identified by specific antibodies.

Rebif® (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of Rebif® is identical to that of natural fibroblast derived human interferon beta. Natural interferon beta and interferon beta-1a (Rebif®) are glycosylated with each containing a single N-linked complex carbohydrate moiety.

Tysabri is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage. Tysabri is used to treat relapsing forms of multiple sclerosis. 		Gilenya™ is a new class of medication called a phingosine 1-phosphate receptormodulator, which is thought to act by retaining certain white blood cells (lympohcytes) in the lymph nodes, thereby preventing those cells from crossing the blood-brain barrier into the central nervous system (CNS). Preventing the entry of these cells into the CNS reduces inflammatory damage to nerve cells.

Early Symptoms
The most common early symptoms of MS include:
* Tingling * Numbness
* Loss of balance
* Weakness in one or more limbs
* Blurred or double vision

Less common symptoms of MS may include
* Slurred speech
* Sudden onset of paralysis
* Lack of coordination
* Cognitive difficulties
Listed above, the early symptoms. I tend to be a poster child for these. The symptoms that occur later on are too numerous just to list. There will be a link included that will get you to a site where these symptoms are listed and explained. Keep in mind that someone may have some of these or many of these, there is no way to tell.
Multiple sclerosis statistics show that approximately 250,000 to 350,000 people in the United States have been diagnosed with this disease. The life expectancy for people with multiple sclerosis is nearly the same as for those without MS. Because of this, multiple sclerosis statistics place the annual cost of MS in the United States in the billions of dollars. MS is five times more prevalent in temperate climates -- such as those found in the northern United States, Canada, and Europe -- than in tropical regions. Furthermore, the age of 15 seems to be significant in terms of risk for developing the disease. Some studies indicate that a person moving from a high-risk (temperate) to a low-risk (tropical) area before the age of 15 tends to adopt the risk (in this case, low) of the new area and vice versa. Other studies suggest that people moving after age 15 maintain the risk of the area where they grew up.

Sunday, September 26, 2010

Fingolimod Receives FDA Approval as First Oral MS Treatment

MSeptember 22, 2010 — The US Food and Drug Administration (FDA) today announced approval of fingolimod (Gilenya, Novartis), the first of the long-anticipated oral treatments for multiple sclerosis (MS). Fingolimod is approved to reduce relapses and delay disability progression in patients with relapsing forms of MS, an FDA release notes.

"Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS, offering patients an alternative to the currently available injectable therapies," Russell Katz, MD, director of the Division of Neurology Products at the Center for Drug Evaluation and Research, said in the FDA statement.


Fingolimod (Gilenya)

Patients should be monitored for bradycardia when starting fingolimod therapy, and treatment is also associated with an increased risk for infection, the release adds. Macular edema has also occurred, and ophthalmologic evaluation is recommended for those taking the drug.

A release from Novartis adds that fingolimod has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to "inform patients and healthcare providers on the safe use and serious risks of Gilenya in treating relapsing forms of MS. The approved REMS includes a medication guide for patients and a letter and safety information guide for healthcare providers."

The company has also initiated a 5-year, worldwide postauthorization safety study to monitor particular safety outcomes and a voluntary pregnancy registry to provide more data on use of fingolimod in women with MS who are pregnant or may become pregnant.

The approval was largely expected after fingolimod received a unanimous endorsement from the FDA's Peripheral and Central Nervous System Drugs Advisory Committee in June.

Given orally, fingolimod acts as a superagonist to sphingosine-1-phosphate receptors on the surface of thymocytes and lymphocytes, reducing the overall number of circulating lymphocytes available to mount an autoimmune reaction to the myelin sheath surrounding axons in MS.

The most frequent adverse reactions reported by patients taking fingolimod in clinical trials include headache, influenza, diarrhea, back pain, elevation of liver enzyme levels, and cough, the FDA statement notes.

Fingolimod was approved in the 0.5-mg dose, the lower of 2 doses investigated in phase 3 trials. The FTY720 Research Evaluating Effects of Daily Oral therapy in Multiple Sclerosis (FREEDOMS) trial and the TRial Assessing injectable interferoN vS FTY720 Oral in RrMS (TRANSFORMS) showed benefit with fingolimod against placebo and against interferon beta, respectively, in reducing relapse rates and new or enlarging lesions on magnetic resonance imaging.

In FREEDOMS, with 24 months of follow-up, there was also less risk of progression of disability with fingolimod vs placebo. The trials were both published in the January 20, 2010, issue of the New England Journal of Medicine.

Two deaths were seen during the TRANSFORMS study, both in the higher-dose group; 1 death was attributed to disseminated primary varicella zoster and the other to herpes simplex encephalitis. Other adverse events with fingolimod in that study included nonfatal herpes virus infections, skin cancer, and elevated liver enzymes.

In FREEDOMS, causes of study discontinuation included bradycardia and atrioventricular conduction block with fingolimod on drug initiation, macular edema, elevated liver enzymes, and mild hypertension. No increase was seen in cancer risk, although the researcher cautioned that longer follow-up is necessary because the risk for cancer is potentially increased by any immunomodulatory agent.
Posted by Steve at Sunday, September 26, 2010

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About Me

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North Grafton, Massachusetts, United States
Well-educated, disabled at this point with Multiple Sclerosis. I am very glad that I was able to do the things that I have been able to do over the years. had to change the picture, this one's more realistic.