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FDA Approves Novartis Psoriasis Drug

Interleukin-17 illustration

Interleukin-17 illustration (Boghog/Wikimedia Commons)

21 January 2015. U.S. Food and Drug Administration approved the biologic drug secukinumab for adults with moderate to severe plaque psoriasis, a common skin disorder. Secukinumab, an antibody designed specifically to address the condition, is marketed by the pharmaceutical company Novartis under the brand name Cosentyx.

Plaque psoriasis is the most common type of psoriasis, an autoimmune disorder, where the body’s immune system is tricked into attacking healthy cells, in this case resulting in inflammation and red, scaly patches of dead skin cells typically in the scalp, or near knees and elbows. According to National Psoriasis Foundation, some 125 million people worldwide have psoriasis, including  7.5 million Americans. Surveys cited by the foundation note that 6 in 10 people with psoriasis consider it to be a large problem in their lives, and people with moderate to severe forms of the disease — about a quarter of the total — experiencing a more negative impact on the quality of their lives.

FDA approved Cosentyx for psoriasis patients who qualify for systemic therapy — treatments that go through the blood stream — or treatments with ultraviolet light, or both. The drug is given as an injection under the skin.

Cosentyx works by binding to the interleukin-17A cytokine, a protein that activates inflammation. By binding to this protein, Cosentyx blocks interleukin-17A from binding to its receptor that triggers the inflammation, thus preventing the red, itchy scales on the skin.

FDA based its approval in part on results of 4 late-stage clinical trials with 2,403 patients having plaque psoriasis, and candidates for systemic or ultraviolet therapies, randomly chosen to receive either secukinumab or a placebo. The results show patients receiving the test drug experience clearer skin based on standard clinical assessments than those receiving the placebo. Novartis says the drug was tested in a total of 10 trials with nearly 4,000 patients.

Under the approval, Novartis will prepare a medications guide with warnings about potential effects of Cosentyx on the immune system, including reports of serious allergic reactions. The most common side-effects of Cosentyx are diarrhea and upper respiratory infections.

Novartis says Cosentyx is the first antibody-type drug approved by FDA to treat moderate to severe forms of psoriasis. On 19 January, the drug was approved by the European Commission for sale in Europe.

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