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FDA approves Novartis' first oral multiple sclerosis drug

To prove the effectiveness of the drug in dealing with MS, the Basel, Switzerland based pharmaceutical giant undertook a study on 1,200 patients suffering from the disease.

The U.S. Food and Drug Administration (FDA) advisory panel approved the first line treatment for multiple sclerosis (MS) Gilenia is the first oral drug that Novaritis, a German drug maker, would sell under this brand name.

Gilenia (generic name Fingolimod) would be used for the relapsing form of MS. The drug significantly reduces MS attacks. The panel had approved it “safe and effective.”

The FDA panel voted 21-3 in favor of the drug, accentuating that the medication is effective in reducing the relapses of MS, which causes a host of movement and cognitive problems.

Study confirms effectiveness of Gilenia
To prove the effectiveness of the drug in dealing with MS, the Basel, Switzerland based pharmaceutical giant undertook a study on 1,200 patients suffering from the disease.

The results showed that patients who were adminstered the drug witnessed 30 percent reduction in the relapse rate compared to those taking other old drugs, such as Bayes's Betaseron and Biogen Idec's Aronex.

This drug can be consumed through mouth as previous preparation needed regular injections.

However Gilenia has some side effects like heart attack along with the lung, liver, and eye toxicity and increased risk of infection.

Gilenia is widely viewed as the most important drug in the Novartis pipeline, and many analysts predict it will achieve blockbuster status with $1 billion or more in annual sales once it hits the market.

How Gilenia works
In MS, white blood cells attack the myelin sheathes that protect nerve cells. Gilenia keeps white blood cells penned up in lymph nodes by taking away the chemical key they need to unlock the lymph-node door.

Fewer white blood cells mean fewer MS attacks. But it also means less protection against infections and cancers.

Side effects
However Gilenia has some side effects like heart attack along with the lung, liver, and eye toxicity and increased risk of infection.

In clinical trials, side effects linked to Gilenia included, elevated liver enzymes, muscular edema (swelling of the central portion of the retina, causing distorted vision), high blood pressure, shortness of breath, bronchitis, diarrhea, bradycardia , which is slowing of the heartbeat, seen only upon first treatment.

Two fatal herpes infections occurred in MS patients treated with Gilenia at 2.5 times the 0.5 mg dose.

Novartis has already assured to set up a careful program for educating and monitoring patients taking the drug. Moreover, the company will continue long-term studies to look for side effects that may occur with longer term use.

The FDA panel suggests that the first dose of the drug should be administered under medical supervision.

Preventive measures during clinical trials
Since the use of the drug could lead to side affects, the healthcare professionals should care preventative measures. These measures include:

- six-hour monitoring for bradycardia and other cardiac problems when patients take their first dose of the drug

- pulmonary function tests before starting fingolimod therapy

- examination by an ophthalmologist after several months to check for muscular edema

About multiple sclerosis
According to the National Multiple Sclerosis Society, about 2.5 million people worldwide suffer from multiple sclerosis, which hinders the ability of nerve cells in the brain and spinal cord to communicate with each other.

Early symptoms of the problem include weakness, tingling, numbness, and blurred vision.

Muscle stiffness and urinary problems are some other alarming signs of MS. Diagnosis is made by the history of symptoms and a neurological exam, often with the help of tests such as an MRI or a spinal tap.