Navigation Links
FDA Approves 1st New Lupus Drug in More Than 50 Years
Date:3/10/2011

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:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves 1st New Lupus Drug in More Than 50 Years
(Date:10/13/2017)... ... October 13, 2017 , ... The American Board of Family Medicine's (ABFM) Board ... Chief Executive Officer, succeeding Dr. James C. Puffer upon his retirement. Dr. Newton will ... Dr. Puffer’s retirement at the end of 2018. Upon assuming the role of President ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of the ... a national organization of elder law and special needs planning attorneys. “Membership in ElderCounsel ... also provides a forum to network with elder law attorneys nationwide,” said Somekh. ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Software Development, has been awarded a contract by the Center for Medicare and ... aims to accelerate the enterprise use of Agile methodologies in a consistent and ...
(Date:10/12/2017)... Francisco, CA (PRWEB) , ... October 12, 2017 ... ... Dr. Cheng, are now treating sleep apnea using cutting-edge Oventus O2Vent ... apnea, a serious sleep disorder characterized by frequent cessation in breathing. Oral appliances ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... , Sept. 27, 2017  Commended for their devotion ... notable awards. Ranked as number one in the South Florida ... time in Inc. 5000 yearly list, the national specialty pharmacy ... Armando Bardisa will soon be honored by SFBJ ... Set to receive his award in ...
(Date:9/25/2017)... AMSTERDAM , Sept. 25, 2017   ... Trial Master File solutions, today—from the IQPC Trial ... Amsterdam , NL)—announced that EastHORN Clinical Services ... its clinical programs and TMF management. EastHORN, a ... Montrium,s eTMF platform to increase transparency to enable ...
(Date:9/23/2017)... , Sept. 22, 2017 Janssen Biotech, Inc. ... response letter from the U.S. Food and Drug Administration ... of sirukumab for the treatment of moderately to severely ... additional clinical data are needed to further evaluate the ... severely active RA. ...
Breaking Medicine Technology: