Advertisement

Syndicate

Physician Resources Home arrow Medical News arrow FDA approves new drug to treat psoriasis
FDA approves new drug to treat psoriasis
Written by NetDoc.com Medical News Feed   

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.

Discuss this article on the forums. (0 posts)

 
Next >

Common Diseases

Swine Flu - Updates and information on H1N1 2009 (AKA Swine Influenza) pandemic.

Ankylosing spondylitis - Current protocols for diagnosis and treatment options.

Wegener granulomatosis - Autoimmune etiology and clinical course.

Diabetes - disease and management information, including diagnosis, typical treatment plans and diabetes supplies.

Advertisement

Medical Careers

The US medical jobs market has stayed hot for health care providers. Whether you believe that a provider shortage is in the offing or that the ratio of physicians-to-patients is too high, physician jobs and nursing jobs abound.

A wide variety of medical jobs can be found in the netdoc health care job listings. Particular strengths include permanent and locum tenens physician jobs, nursing jobs across the US, and radiology positions.

Other resources include physician salary information, medical career guidance, and the ability to post physician jobs.

Polls

When hiring your medical practice office manager, what was the most important consideration?
 
Copyright 2005 - 2019 Medical Resource Group, LLC. All rights reserved.