For Immediate Release
January 21, 2015
The U.S. Food and Drug Administration today approved Cosentyx (secukinumab) to treat adults with moderate-to-severe plaque psoriasis.
Psoriasis is a skin condition that causes patches of skin redness and irritation. Psoriasis is an autoimmune disorder, and occurs more commonly in patients in with a family history of the disease, and most often begins in people between the ages of 15 and 35. The most common form of psoriasis is plaque psoriasis, in which patients develop thick, red skin with flaky, silver-white patches called scales.
Cosentyx’s active ingredient is secukinumab. Secukinumab is an antibody that binds to a protein (interleukin (IL)-17A) which is involved in inflammation. By binding to IL-17A, secukinumab prevents it from binding to its receptor, and inhibits its ability to trigger the inflammatory response that plays a role in the development of plaque psoriasis.
Cosentyx is administered as an injection under the skin. It is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected), phototherapy (ultraviolet light treatment) or a combination of both.
“Plaque psoriasis can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available to patients,” said Amy Egan, M.D., M.P.H., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.
Cosentyx’s safety and effectiveness were established in four clinical trials with a total of 2,403 participants with plaque psoriasis who were candidates for phototherapy or systemic therapy. Participants were randomly assigned to receive Cosentyx or a placebo. The results showed that Cosentyx achieved greater clinical response than placebo, with skin that was clear or almost clear, as assessed by scoring of the extent, nature and severity of psoriatic changes of the skin.
Cosentyx is being approved with a Medication Guide to inform patients that, because Cosentyx is a medicine that affects the immune system, patients may have a greater risk of getting an infection. Serious allergic reactions have been reported with the use of Cosentyx. Caution should be exercised when considering the use of Cosentyx in patients with a chronic infection or history of recurrent infection, and in patients with active Crohn’s Disease. The most common side effects include diarrhea and upper respiratory infections.
Cosentyx is marketed by East Hanover, New Jersey-based Novartis Pharmaceuticals Corporation.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.