June 13, 2010

Fingolimod, First Pill for Multiple Sclerosis Wins Advisory Panel Approval

First Oral Pill to be Approved for Multiple Sclerosis Soon.
This is nothing short of great news within the medical community as the first oral pill designed to treat multiple sclerosis (MS) is on its way to final approval by the United States FDA.

An advisory committee approved the drug, and now it is in the hands of the FDA to make the final decision.

Typically, the FDA follows recommendations from the committee. The advisory panel is made up of experts who are not directly affiliated with the FDA.

The pill which will be marketed with the name Gilenia, has its pharmaceutical name as fingolimod and manufactured by Novartis.

Side effects skepticism

The panel was skeptical about the approval because of a number of serious side effects associated with the pill including decreased lung function and heart problems. In the end, however, they based their approval decision on the fact that the benefits outweighed the risks.

Now it is up to the FDA to decide if the benefits are worth it.

The decision is expected to come by September of this year. If approved, the pill is expected to generate a billion dollars in annual sales for the company.

Several other drug manufacturer’s have also been working on similar oral pills and are working on getting their versions approved for use in the US.

How it will work

Fingolimod will be used in the treatment of relapsing multiple sclerosis (MS) in adults and children who are at least 10 years old.

The pill is expected to help delay the symptoms associated with the onset of multiple sclerosis. It will not cure MS, but will only delay the onset and also the the frequency of relapse symptoms.

MS usually attacks people in their 20s and progressively gets worse.

The disease affects the nervous system and often results in the sufferer being unable to walk or talk.

Before taking Fingolimod

You should not use fingolimod if you are allergic to it, or if you have certain serious heart conditions, especially:
  • severe heart failure (that required you to be in the hospital);
  • "AV block" or sick sinus syndrome (unless you have a pacemaker);
  • long QT syndrome; or
  • recent (within the past 6 months) heart attack, stroke, "mini-stroke" or TIA, chest pain (unstable angina), or other serious heart problem.
Your doctor will check your heart function before you start taking fingolimod.

Some heart rhythm medications can cause unwanted or dangerous effects when used with fingolimod. Your doctor may change your treatment plan if you also use: amiodarone, disopyramide, dofetilide, flecainide, dronedarone, ibutilide, mexiletine, procainamide, propafenone, quinidine, or sotalol.

Before you take fingolimod, tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 1 month before taking fingolimod.

Tell your doctor if you have ever had:
  • an active or chronic infection;
  • a heart rhythm disorder;
  • chest pain (angina) or other heart problems;
  • a heart attack or stroke, including "mini-stroke";
  • high or low blood pressure;
  • fainting spells;
  • diabetes;
  • skin cancer;
  • liver disease;
  • an eye condition called uveitis; or
  • asthma, sleep apnea, or other breathing disorder.
Using fingolimod may increase your risk of developing skin cancer (melanoma).

Fingolimod may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using fingolimod, and for at least 2 months after your last dose.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of fingolimod on the baby.

It may not be safe to breastfeed while using this medicine.

Novartis will continue with a five year study examining the long term side effects of the pill.

Read Also: What is Multiple Sclerosis?

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