The new psoriasis drug Secukinumab (Cosentyx), a IL-17A-inhibiting antibody, approved by the FDA

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.