Custom Search

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.

=====================================================================================================
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies and pharmaceutical manufacturers from all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice for Pharmaceutical Manufacturing (c GMP guidelines ) and latest news and new drugs developments.

=====================================================================================================
You may also like following articles

Whar is Referance Listed Drug  ? ( RLD )

What is Pharmaceutical Equivalents

What is Pharmaceutical Alternatives

What is Therapeutic Equivalents


Do Physical properties contribute to drug activity.

What is drug receptor , How a drug resistance occurs

Mechanism of drug resistance

What is drug interaction

Drug interaction, and its examples

What is first pass metabolism of a drug

What is What is 510(k) Clearances ?

What is 510(k) Clearances,

Premarket Notification for medical devices - PMN or 510(k)

What is a drug interaction

Examples of drug interactions


Antibiotic Definition and classification


Antibiotic resitance and Antibiotic resistance mechanism

Antioxidants food suppliments

Vitamin D Details on FDA cautions on accurate dosage of Vitamin D


What is an antibody? what is monoclonal and polyclonal antibodies?

Terminologies In vaccine Production

Multi stage testing of Virus vaccine production

Testing of vaccines at different stages of production

TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION

Enzyme linked immunosorbent assay ELISA

Raido Immuno assay

http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.

http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in

pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing


Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coefficient of a disinfectant

Sterility testing

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controlling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs

BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Electronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates

Here is an interesting article on world wide pharmaceutical industry and making a carrier in one of pharmaceutical companies article on Pharmaceutical Industry pharmaceutical industry

Find a Job in Pharmaceutical Company
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies
Here are some interesting articles on Quality assurance systems for pharmaceutical company

1.Quality assurance in pharma industry

2.Quality by designe concept for pharmaceutical industry

3.Quality by designe concept in pharmaceutical industryan explanation

1 comment:

paresh kalubhai 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.

Posted by: Martin

How to sucessfuly activate and receive our articles on pharmaceuticals by E-Mail

Dear readers if you wish to receive our articles on pharmaceutical automatically into your email Inbox , as and when we write a new article over this website, then follow these 3 simple steps.


1.You should write your Email ID in the box provided and push the subscribe butten


2.Enter the text code that we show you in a small new browser window after you enter your email ID.

3.Log in to your email and Cheke our verification email sent by "FEEDBURNER" , there you should verify the link we send you by email.




Enter your email address get our articles by email whenever this website is updated





Delivered by FeedBurner



Join the list of our readers from Universities ,Research and Development centers Pharmaceutical Companies from all over the world.











Pharma Research Regulatory Guidelines Website
Texas Dallas, TX 75211 US
Email: editor@pharmacistspharmajournal.org Website: http://pharmacistspharmajournal.org/
Copyright © 2008-2015 all rights reserve www.pharmacistspharmajournal.org