TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients performing all FDA submissions. TARGET HEALTH receives daily updates of new developments at FDA. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available. 

FDA Approves New Drug to Treat Psoriasis

Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. About 6 million people in the US have plaque psoriasis which is characterized by thickened patches of inflamed, red skin, often covered with silvery scales. The FDA has approved Stelara (ustekinumab), a biologic product for adults who have a moderate to severe form of psoriasis. 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.

For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

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