Navigation Links
FDA Approves 1st New Lupus Drug in More Than 50 Years

WEDNESDAY, March 9 (HealthDay News) -- The U.S. Food and Drug Administration on Wednesday gave lupus patients their first new treatment option in more than 50 years when it approved Benlysta as a way to ease the painful symptoms of this debilitating autoimmune disorder.

Injected directly into a vein, Benlysta is the first drug designed to target a protein that may reduce the number of abnormal B cells believed to be at the root of lupus, the FDA said in a news release. The last lupus drugs approved by the agency were Plaquenil (hydroxychloroquine) and corticosteroids; both were given the agency's blessing in 1955. Back in 1948, aspirin was approved to treat the disease.

Lupus strikes women far more often than men, and symptoms typically first appear between the ages of 15 and 44. The joints, skin, kidneys, lungs, heart and brain can all be affected, and when symptoms flare up they include swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss and fatigue, the FDA said.

According to the agency, there are between 300,000 and 1.5 million lupus sufferers in the United States. Black women are three times more likely than white women to get the disorder.

"Benlysta, when used with existing therapies, may be an important new treatment approach for health-care professionals and patients looking to help manage symptoms associated with this disease," said Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.

The approval was widely expected after an FDA advisory panel voted 13-2 in November to recommend approval of the drug, the Los Angeles Times reported, and Benlysta is expected to become a top seller for its maker, Human Genome Sciences Inc., of Rockville, Md.

Benlysta's arrival has been much heralded because it comes on the heels of decades of disappointing efforts to craft new treatments for lupus, Sandra Raymond, president of Lupus Foundation of America, told the Times.

"It's an historic day. It really does open a door," Raymond told the newspaper. "Not that Benlysta is a miracle drug. It's not. I think the lupus community is sanguine about that. But they know that there are other companies coming behind" Human Genome.

More information

For more on lupus, go to the U.S. National Institutes of Health.

-- HealthDay Staff

SOURCES: March 9, 2011, news release, U.S. Food and Drug Administration, Los Angeles Times

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Approves First 3D Mammogram Device
2. FDA Approves First Pacemaker Deemed Safe During MRIs
3. FDA Approves First Drug to Prevent Premature Births
4. Swiss agency approves clinical trial of UCI-created neural stem cell therapy
5. ACGME board approves final duty hour and supervision standards for resident education
6. FDA Approves 1st Oral Drug to Reduce MS Relapses
7. FDA approves Merz Pharmaceuticals Xeomin (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm
8. Early detection of cancer: The FDA approves procedure discovered by EPFL researchers
9. FDA approves first human neural stem cell clinical trial to treat brain tumors
10. FDA Approves Stemedica IND for Ischemic Stroke Clinical Trial
11. New York State Office of Mental Health Approves New High Performance Polycarbonate Sheet for Use in All Facilities
Post Your Comments:
Related Image:
FDA Approves 1st New Lupus Drug in More Than 50 Years
(Date:6/26/2016)... ... 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop ... The fitness app plans to fix the two major problems leading the fitness industry today:, ... all type program , They don’t eliminate all the reasons people quit their ...
(Date:6/25/2016)... ... 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due to ... a new, often overlooked aspect of head lice: the parasite’s ability to live away from ... common occurrence, but a necessary one in the event that lice have simply gotten out ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a method ... —Johnson is one of the first doctors to perform the treatment. Orthobiologics are ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced ... feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as a ... has released tools for healthy coping following a traumatic event. , Trauma sufferers tend ...
(Date:6/24/2016)... ... 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida ... their peers for this recognition are considered among the top 2 percent of lawyers ... as members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016   Bay ... Rehabilitation Network,s Dean Center for Tick Borne ... Medicine and Rehabilitation, MIT Hacking Medicine, University of ... Innovation, today announced the five finalists of ... Lyme disease.  More than 100 scientists, clinicians, researchers, ...
(Date:6/24/2016)... Dehaier Medical Systems Ltd. (NASDAQ: ... and sells medical devices and wearable sleep respiratory products ... cooperation agreement with Hongyuan Supply Chain Management Co., Ltd. ... 20, 2016, to develop Dehaier,s new Internet medical technology ... will leverage Hongyuan Supply Chain,s sales platform to reach ...
(Date:6/24/2016)... LEXINGTON, Mass. , June 24, 2016   ... specialty pharmaceutical company developing innovative inhaled drugs, announced today ... when Russell Investments reconstituted its comprehensive set ... 2016. "This is an important milestone for ... "It will increase shareholder awareness of our progress in ...
Breaking Medicine Technology: