Navigation Links
FDA Approves 1st Oral Drug to Reduce MS Relapses
Date:9/22/2010

By Serena Gordon
HealthDay Reporter

WEDNESDAY, Sept. 22 (HealthDay News) -- The U.S. Food and Drug Administration on Wednesday approved the first oral drug to reduce relapses of multiple sclerosis, the nervous system disorder that has traditionally been treated with injectable drugs.

Gilenya (fingolimod) is designed to reduce relapses and delay the progression of debilitating symptoms in patients with relapsing forms of multiple sclerosis (MS). The drug, which works by altering the immune system response, will be available in capsule form.

Research published in January in the New England Journal of Medicine found that Gilenya reduced relapse rates in people with relapsing-remitting multiple sclerosis. However, as is often the case with immune-suppressing medications, there were concerns about side effects, including an increased risk of serious infections and, possibly, cancer.

"Oral drugs are what people with MS have been wishing for a long time. This is wonderful news for people with MS," Dr. John Richert, former executive vice president of research and clinical programs for the National Multiple Sclerosis Society, told HealthDay at the time the research was published. The drug appears to be "quite effective," and at the moment, appears to have a reasonable risk-benefit ratio. "However," he added, "it will be very important for people with MS and their physicians to remain vigilant and be on the lookout for side effects."

The January research was funded by the drug's manufacturer, the Swiss pharmaceutical company Novartis.

Multiple sclerosis is a chronic, potentially disabling illness that's believed to be an autoimmune disorder. In MS, the body's natural defense system mistakenly attacks the fatty substance that protects the nerves (myelin) in the brain and spinal cord. About 400,000 Americans have multiple sclerosis, which is characterized by periods of well-being followed by periodic relapses, according to the multiple sclerosis society.

Until now, the existing treatments for reducing relapses in relapsing MS were all injectable medications, which Richert said is sometimes a barrier for people to start early treatment. He said that treatments may be more successful if they're started early in the course of the disease, so he's hoping that having oral medications will help people start treatment sooner.

The two Gilenya studies published in January were phase 3 studies. One study included more than 1,000 people with relapsing-remitting MS. The study participants were randomly selected to receive a daily dose of 0.5 milligrams (mg), 1.25 mg or a placebo.

Annual relapse rates were less than 1 percent each year, and 54 percent less for the lower dose of Gilenya and 60 percent for the higher dose. The study also found slower disease activity and progression.

In the second study, 1,153 people with relapsing-remitting MS were randomly assigned to receive a daily dose of 0.5 mg or 1.25 mg of Gilenya or a weekly dose of 30 micrograms of interferon beta-1a (Avonex) for one year. The annual relapse rate on either drug was less than 1 percent in this study as well. However, the people on Gilenya had up to a 52 percent lower relapse rate. This study found no significant differences in disease progression between the two treatments.

Both studies found that the lower dose of the drug was better tolerated. A small number of serious infections occurred, including two deaths from herpes infections in these studies. And, there appeared to be a higher incidence of cancer in people taking Gilenya.

Novartis said Wednesday that the FDA approved a 0.5-milligram daily dose of Gilenya.

More information

To learn more, visit the National Multiple Sclerosis Society.

SOURCES: Sept. 22, 2010, news release, U.S. Food and Drug Administration; John Richert, M.D., executive vice president, research and clinical programs, National Multiple Sclerosis Society, New York City; Jan. 20, 2010, New England Journal of Medicine, online


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Kaiser Permanente Approves $170 Million in Community Benefit Grants in 2009
2. The American Association of Anatomists approves guidelines for body donation programs
3. Golden Meditech Shareholders Approves of Name Change
4. New Jersey Approves Initiative to Expand the Number of Wound Care Certified Professionals
5. Congress Approves Bill Curbing Internet Tobacco Sales in Victory for Kids and Taxpayers
6. House of Representatives Approves Health-Care Reform Bill
7. New York State Office of Mental Health Approves New High Performance Polycarbonate Sheet for Use in All Facilities
8. FDA Approves Stemedica IND for Ischemic Stroke Clinical Trial
9. FDA approves first human neural stem cell clinical trial to treat brain tumors
10. Early detection of cancer: The FDA approves procedure discovered by EPFL researchers
11. FDA approves Merz Pharmaceuticals Xeomin (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... MA (PRWEB) , ... December 08, 2016 , ... California ... in medical payments per workers’ compensation claim in 2013 and 2014, according to ... Compensation Research Institute (WCRI) . , According to the study, medical payments per claim ...
(Date:12/8/2016)... ... December 08, 2016 , ... The ... from offices headquartered in Hamilton County, is embarking on a charity drive with ... in finding new homes for orphaned or neglected senior dogs in the Cincinnati ...
(Date:12/8/2016)... Payne, AL (PRWEB) , ... December 08, 2016 ... ... offering insurance and financial consulting services to residential and commercial clients in the ... awareness and support for Nobis Works. , Since 1977, Nobis Works has built ...
(Date:12/7/2016)... ... , ... Kenall Manufacturing, a leader in sealed healthcare lighting for more than ... multi-function, sealed, LED luminaire that meets the needs of everyone in the patient room ... , A 2’ x 4’ model features four modes: reading, ambient, standard and ...
(Date:12/7/2016)... (PRWEB) , ... December 07, ... ... it has acquired Presence Technology, S.L. (“Presence”) for a purchase price of ... adjustments and other considerations. Presence’s annual revenue is approximately $13.2 million. Headquartered ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... PHOENIX , Dec. 8, 2016 A ... by the National Institutes of Health (NIH) to ... State University.  The grant will seek ... NeuroEM,s head device, which utilizes electromagnetic waves to treat ... of this novel technology to possibly treat other neurologic ...
(Date:12/8/2016)... Ariz., Dec. 8, 2016  Economic growth in the ... purchasing and supply management executives in their December 2016 ... the economic recovery that began in mid-2009, as indicated ... Business ® . The manufacturing sector is optimistic ... in 16 manufacturing industries, and the non-manufacturing sector indicates ...
(Date:12/8/2016)... Dec. 8, 2016  Hanson Research, an innovative ... testing and diffusion testing instruments for the pharmaceutical ... Teledyne Instruments, Inc. ("Teledyne"). The move is designed ... precision testing instruments, as well as expand resources ... new products and services. Logo - ...
Breaking Medicine Technology: