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:1/16/2017)... , ... January 16, 2017 , ... ... been appointed Chief Executive Officer of the medical device company, effective immediately. , ... Robert Storey. “Kevin has a strong track record in medical device market ...
(Date:1/15/2017)... ... 2017 , ... Going above and beyond the practical impact ... communities around the world by offering the Gensuite team and their services to ... members to become involved in a cause that is bigger than themselves and ...
(Date:1/15/2017)... ... 15, 2017 , ... "On Tour is a music themed slideshow production package ... Christina Austin - CEO of Pixel Film Studios. , On Tour’s new slide ... and animation of their slideshows. Place each slide on top of another slide or ...
(Date:1/15/2017)... ... January 15, 2017 , ... The Gravity Vault Indoor Rock Climbing Gym is ... wraps up on the 14,000+ square foot climbing gym, the owners anticipate to open ... in New Jersey and two in New York. With this being its first location ...
(Date:1/14/2017)... ... January 13, 2017 , ... According to a ... Mediterranean diet may lower the risk of type 2 diabetes, Alzheimer’s, and cardiovascular ... health and wellness benefits linked to a Mediterranean diet are only some of ...
Breaking Medicine News(10 mins):
(Date:1/16/2017)... SAN FRANCISCO, Calif. , Jan. 16, 2017 /PRNewswire/ ... that on January 3, 2017 and January 16, 2017 ... the grant of inducement stock options to purchase an ... new employees. These awards were granted pursuant to the ... inducement material to the new employees entering into employment ...
(Date:1/16/2017)... , Jan. 16, 2017 CBDRx, the world,s ... amounts of phyto-nutrient rich hemp extract to Veteran,s groups ... of their proprietary hemp extract to Veteran,s groups across ... best hemp company in the world and through their ... nutritious, full spectrum phyto-nutrient rich hemp extract available. ...
(Date:1/15/2017)... 16, 2017 Le conseil d,administration de ... de collagène pour la régénération de tissus humains, annonce la ... directeur général avec effet immédiat. ... Bill est un dirigeant expérimenté à ... postes de gestion générale et de direction au sein de ...
Breaking Medicine Technology: