FDA Approval Sought for New MS Drug


Following a huge success of multiple sclerosis (MS) pills, Biogen Idec, Inc. sought FDA for approval for the launch of the third MS drug, last Tuesday.  Plegridy is a new pegylated subcutaneous interferon injectable drug to treat relapsing forms of multiple sclerosis. According to Biogen Idec, Inc, the filing demonstrates their dedication to the treatment of MS, both through the discovery of the medications and development of innovative solutions that enhance treatment for people living with this disease.

The company also added that the monitoring submission was based on the results from the first year of the two-year global Phase 3 ADVANCE study. The clinical data revealed that the drug finally met all primary and secondary process’s endpoints to reduce the disease’s relapses, activity, disability progression, and brain lesions. It showed favorable responses to safety and tolerability profiles in one year.

If FDA approves Plegridy, it will be the newest addition to the interferon class for MS first-line treatment. The company also plans to market the drug to Europe in the coming weeks.

How is it better?

Plegridy is the new version and predecessor of the hugely successful Avonex, a product of Weston Biotechnology MS treatment. While both brands contain the same active ingredient, interferon beta, Biogen has attached a polymer called peg or polyethylene glycol to the drug, which allows patients to lessen their therapy schedule. Administering the drug subcutaneously is also less painful and convenient, unlike other MS drugs.

The executive vice president of research and development for Biogen, Douglas E. Williams states that Plegridy has met its objective to reduce the disease’s effects, including relapses and worsening disabilities.
In the later stage of clinical trials, Plegridy is administered to patients every other week, rather than every week.

What is Multiple sclerosis?

Multiple sclerosis is a chronic autoimmune and inflammatory disease of the central nervous system, which disrupts the communication between the brain and other parts of the body. MS affects approximately 400,000 people in the U.S. and 2.5 million worldwide. Many people experience their first symptoms at age 20 and 40.

For most people with multiple sclerosis, episodes of relapses are initially followed by recovery periods or remissions. Recovery periods may be incomplete, which leads to progressive decline in function and increased disability.

Patients with MS often experience loss of balance, muscle weakness, and progressive physical function decline. Other symptoms include pain in some parts of the body, dizziness, blurring vision, electric shock sensations that occur with certain head movements, and slurred speech. Patients with MS are also sensitive to heat. Small increases in temperature can aggravate or trigger MS symptoms.

Celebrities with MS

It is true that there are no known medical cures for MS and no one is immune to it, even the stars. Tamia Hill, Montel Williams, David and Alan Osmond, Anne Romney, Niel Cavuto, and Richard Cohen are just a few celebrities who have MS. Most of these celebrities focused on healthy diet, therapy, fitness, and treatment to improve overall wellness. All of them experienced symptoms of MS throughout the progression of the disease and initial attack, like mood swings and fatigue.

Earlier diagnosis and treatment, as well as swift treatment is important. Prompt medications can help prevent disabilities and cut the recurrence of symptoms. Earlier diagnosis means that you, and your physicians can work together to fight the disease better.

Plegridy Side Effects

According to the clinical data based on the first year of the two-year global Phase 3 Plegridy ADVANCE trial, the drug demonstrated strong efficacy in significantly reducing the disease, including relapses and disability progression.  There are adverse effects like redness in the injected area and influenza like symptom,s but they are tolerable.

The real cause of MS is yet unknown to science, and the drugs are only for treatment of symptoms. According to Russell Katz, director of the Neurology products, in the FDA for Drug and Evaluation and Research, there is no drug that provides a cure for multiple sclerosis, so it is important to have a variety of treatment options available for patients.

Written by: Janet Grace Ortigas

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