Wednesday, September 22, 2010

US FDA approved first oral drug to reduce Multiple Sclerosis MS relapses

US FDA approved first oral drug to reduce Multiple Sclerosis MS relapses
The United States F D A approved new drug to treat Multiple Sclerosis.
Gilenya capsules containing fingolimod as active molecule is approved by US FDA on 22-09-2010 for treatment of Multiple Sclerosis, the drug can be used to reduce relapses and delay disability progression in patients affected with relapsing forms of multiple sclerosis (MS).

Gilenya (fingolimod) is the first oral drug that can delay the progression of disability and lessen the frequency and severity of symptoms of multiple sclerosis (MS) it is an option for at present available injectable therapies.

Information about multiple sclerosis (MS):
Multiple sclerosis MS is disease condition which is a chronic, often disabling, disease which affects the central nervous system—the brain, spinal cord, and optic nerves , where a normal communication from central nervous system to other parts of body is disturbed resulting in to disability of the body part affected.

It is developed due to autoimmune disease condition where body's own defense mechanism attacks its own body tissues , here in case of Multiple sclerosis mylin sheth that covers nerve fiber becomes target of auto immune attack.

The progress, severity, and specific symptoms of MS are unpredictable and may vary from one person to person. Symptoms may be mild, like numbness in the limbs, or may be as severe as paralysis or loss of vision.

Information about Fingolimod:


Fingolimod is chemically derived from myriocin a antibiotic and a metabolite from fungus Isaria sinclairii.
Fingolimod molecule is structurally similar to sphingosine.
Sphingosine a constituent of sphingolipids , that form cell membrane lipids constituting sphingomyelin.
And sphingomyelin play a vital role in producing chemical signals which are responsible for many cellular process activation, one of which is activation of lymphocyte and migration in immune reactions.
Fingolimod owning to structural similarity with sphingosine get phosphorylated instead of sphingomyelin.
and it is responsible for blocking lymphocytes in lymph nodes thereby preventing them from getting in to central nervous system, brain and spinal cord
Thus Fingolimod blocks lymphocytes in lymph nodes thereby preventing them from getting in to central nervous system, brain and spinal cord, lymphocytes mediate auto immune responses , some of the immune responses mediated by lymphocytes are autoimmune and are harmful to patients affected with multiple sclerosis (MS).
Drug Gilenya (fingolimod) is found to be reducing the severity of multiple sclerosis (MS).
FDA said in its press release that patients using Gilenya must be monitored for a decrease in heart rate upon starting the drug.

As Gilenya reduces immune response it is likely that there is a risk getting infections.
US FDA also recommend an ophthalmologic evaluation as in some cases serious eye problems (macular edema) are reported in patients taking the drug Gilenya.
Adverse reactions:
Reported in clinical trial in patients taking Gilenya are headache, influenza, diarrhea, back pain, elevation of certain liver enzymes and cough.
The drug will be available as capsules of strength 0.5 milligram.
Gilenya is made by Pharmaceutical Manufacturing Company from Switzerland Novartis, Basel, Switzerland.
Congratulations to Novartis, Basel, Switzerland.

1 comment:

Paresh Bharodiya said...

many many thanks to novartis for developing such an effective molecule for multiple sclerosis.its a great gift indeed to the patients with MS from novartis.