 |
| Health News > FDA Approves New Drug to Treat Psoriasis | 
|
ADVERTISEMENT | ADVERTISE WITH US
Health News Videos
The Importance of Monitoring Vitamin D Status in the U.S.
Dr. Howard Nash
The Importance of Monitoring Vitamin D Status in the U.S.
Dr. Howard Nash
The NIH Common Fund's Human Microbiome Project
Top News
Subscribe to this feed:
« Back
Via FDA Press - The U.S. Food and Drug Administration today approved Stelara (ustekinumab), a biologic product for adults who have a moderate to severe form of psoriasis. Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. About 6 million people in the United States have plaque psoriasis which is characterized by thickened patches of inflamed, red skin, often covered with silvery scales.
“This approval provides an alternative treatment for people with plaque psoriasis, which can cause significant physical discomfort from pain and itching and result in poor self-image for people who are self-conscious about their appearance,” said Julie Beitz, M.D., director, Office of Drug Evaluation III, in the FDA’s Center for Drug Evaluation and Research.Stelara is a monoclonal antibody, a laboratory-produced molecule that mimics the body’s own antibodies that are produced as part of the immune system.
The biologic treats psoriasis by blocking the action of two proteins which contribute to the overproduction of skin cells and inflammation.Three studies of 2,266 patients evaluated the biologic’s safety and effectiveness.Since Stelara reduces the immune system’s ability to fight infections, the product poses a risk of infection.
Serious infections have been reported in patients receiving the product and some of them have lead to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer.
The FDA is requiring a risk evaluation and mitigation strategy or REMS for Stelara that includes a communication plan targeted to healthcare providers and a medication guide for patients.Stelara is manufactured by Centocor Ortho Biotech Inc. of Horsham, Pa., a wholly-owned subsidiary of Johnson & Johnson of New Brunswick, N.J.
Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183851.htm
FDA Approves New Drug to Treat Psoriasis
| Sep 25th 2009 | Drugs Integumentary Autoimmune |
Via FDA Press - The U.S. Food and Drug Administration today approved Stelara (ustekinumab), a biologic product for adults who have a moderate to severe form of psoriasis. Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. About 6 million people in the United States have plaque psoriasis which is characterized by thickened patches of inflamed, red skin, often covered with silvery scales.
“This approval provides an alternative treatment for people with plaque psoriasis, which can cause significant physical discomfort from pain and itching and result in poor self-image for people who are self-conscious about their appearance,” said Julie Beitz, M.D., director, Office of Drug Evaluation III, in the FDA’s Center for Drug Evaluation and Research.Stelara is a monoclonal antibody, a laboratory-produced molecule that mimics the body’s own antibodies that are produced as part of the immune system.
The biologic treats psoriasis by blocking the action of two proteins which contribute to the overproduction of skin cells and inflammation.Three studies of 2,266 patients evaluated the biologic’s safety and effectiveness.Since Stelara reduces the immune system’s ability to fight infections, the product poses a risk of infection.
Serious infections have been reported in patients receiving the product and some of them have lead to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer.
The FDA is requiring a risk evaluation and mitigation strategy or REMS for Stelara that includes a communication plan targeted to healthcare providers and a medication guide for patients.Stelara is manufactured by Centocor Ortho Biotech Inc. of Horsham, Pa., a wholly-owned subsidiary of Johnson & Johnson of New Brunswick, N.J.
Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183851.htm
Related articles
- NIH Study Reveals New Genetic Culprit in Deadly Skin Cancer
- Boxed Warning Required for Botox, All Botulinum Toxin Products
- Scientists Identify a Potential Target that May Provide a New Approach to Melanoma Treatment
- FDA Alerts Public about Danger of Skin Numbing Products
- FDA Approves Updated Labeling for Psoriasis Drug Raptiva
- FDA issues warning for use of Fentanyl Patch
- Approximately $2 Million of Potentially Harmful Cosmetic Eye Product Seized
Add your own comments
Comments:
No commentsHealth Resource Centers
|
Copyright 2009-2010 Emma Concepts, Inc. All rights reserved. |
About us & FAQ |
Terms of Service |
Privacy Policy |
Advertise
Healthimize.com’s content is for educational purposes only and this page and other pages on Healthimize do not contain medical advice. The information on this website is not a substitute for professional medical advice. Users further agree to abide by the terms of service. Trademarks are properties of their respective owners. |