The US Food and Drug Administration (FDA) has approved secukinumab (Cosentyx, Novartis) to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Secukinumab is a fully human monoclonal antibody that inhibits the proinflammatory cytokine interleukin 17A. It is administered via subcutaneous injection.
Plaque psoriasis, the most common form of psoriasis, is characterized by thick, red skin with flaky, silver-white patches.
"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," Amy Egan, MD, deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, said in a news release.
The FDA Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously for approval of secukinumab for plaque psoriasis in October 2014, as reported by Medscape Medical News.
The safety and effectiveness of secukinumab were established in four clinical trials involving roughly 2400 patients with plaque psoriasis who were candidates for phototherapy or systemic therapy.
The results showed that secukinumab 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," the FDA said in the release.
The most common adverse effects include diarrhea and upper respiratory infections.
Serious allergic reactions have been reported with secukinumab, and the FDA says caution should be exercised when considering the drug in patients with a chronic infection or history of recurrent infection, as well as in patients with active Crohn's disease. Secukinumab was approved with a medication guide to alert patients they may be at greater risk for infection while taking secukinumab.
Earlier this month, the European Commission approved secukinumab as a first-line systemic treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
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Cite this: FDA Clears Secukinumab (Cosentyx) for Plaque Psoriasis - Medscape - Jan 21, 2015.
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