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.

Saturday, October 17, 2009

Fampridine-SR

Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine, or 4-AP). Data collected in laboratory studies found that fampridine can improve the communication between damaged nerves, which may result in increased neurological function.


Positive vote by FDA advisory committee for Fampridine-SR
Acorda Therapeutics, Inc. has announced the U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs (PCNSD) Advisory Committee voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice daily demonstrated substantial evidence of effectiveness as a treatment to improve walking in people with multiple sclerosis (MS) and voted 10 to 2 (1 abstention) that it is clinically meaningful and can be safe for use.

"We are pleased with the outcome of today`s Advisory Committee meeting. People with MS have an urgent need for therapies to improve their walking, which is essential to conducting their activities of daily life. If approved, Fampridine-SR would be the first medicine to improve walking in people with MS," said Ron Cohen, M.D., Acorda Therapeutics President and CEO. "This Advisory Committee meeting is an important milestone in the development of Fampridine-SR, and we look forward to working with the FDA as it completes its review of Acorda`s New Drug Application."

The Committee also recommended by a vote of 12 to 1 that Acorda be required to evaluate the effects of doses lower than 10 mg twice daily, but by a 10 to 2 vote (1 abstention) that these studies not be required prior to approval.

At the request of the FDA, the Committee discussed possible conditions for use, including for patients with renal impairment or history of seizure. Acorda has proposed a Risk Evaluation and Mitigation Strategy (REMS) program, which could include healthcare professional and patient education around appropriate use of Fampridine-SR.

The FDA seeks the advice of an advisory committee such as the PCNSD when evaluating a potential new treatment, but is not required to follow its recommendation. The current Fampridine-SR Prescription Drug User Fee Act (PDUFA) date set by the FDA is October 22, 2009; the PDUFA date is the target date for the FDA to complete its review of Fampridine-SR.
Posted by Steve at Saturday, October 17, 2009

No comments:

Post a Comment

Subscribe to: Post Comments (Atom)

Blog Archive

About Me

My photo
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.