Wed. Jan 21, 2015 - The United States Food and Drug Administration today okayed Cosentyx (secukinumab) as a psoriasis treatment to treat adult patients with moderate-to-severe plaque psoriasis.
The drug is marketed by East Hanover, New Jersey-based Novartis Pharmaceuticals Corporation.
Psoriasis as a skin condition causes patches of skin redness and irritation. Psoriasis is an autoimmune disorder, and people with a family history of the disease are more likely than others to develop trhe disease. They often develop the disease between the ages of 15 and 35 years. In the most common form, psoriasis which is called plaque psoriasis in the case develops with thick, red skin with flaky, silver-white patches called scales.
Cosentyx is made of an active ingredient called secukinumab. Secukinumab works as an antibody to bind to a protein, specifically, interleukin (IL)-17A which is involved in inflammation. By binding to IL-17A, secukinumab prevents the inflammatory protein from binding to its receptor, and therefore inhibits its ability to trigger the inflammatory response in the development of plaque psoriasis.
As a treatment, Cosentyx is applied via injection under the skin. The drug is intended for those who are to receive systemic therapy, phototherapy (ultraviolet light treatment) or a combination of both.
The safety and efficacy of Cosentyx was tested in four clinical trials with 2,403 patients with plaque psoriasis who were assigned phototherapy or systemic therapy. Patients were randomly assigned to receive Cosentyx or placebo. As a resul, Cosentyx achieved greater clinical response than placebo with the skin cleared or almost cleared.
Cosentyx is being approved with a Medication Guide to inform patients because use of this medication can impose some risk. Cosentyx affects the immune system, patients receiving the psoriasis treatment are more likely than those who do not receive the treatment to get an infection. Serious allergic reactions were also observed in patients using 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.
Originally posted by the FDA website with some content edited.
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