FDA Approves Psoriasis Systemic Therapy 

The US Food and Drug Administration has approved Siliq injection (brodalumab; Valeant Pharmaceuticals) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy and have failed to respond—or have stopped responding—to other systemic therapies.

Psoriasis is an autoimmune disorder that occurs most commonly in patients who have a family history of the disease. Symptoms of psoriasis are patches of red skin that is flakey; these typically begin occurring in people between the ages of 15 and 35 years.

The decision to approve brodalumab was based on data from three randomized, placebo-controlled clinical trials with a total of 4373 adult participants with moderate-to-severe plaque psoriasis who were also candidates for systemic therapy or phototherapy. Overall, patients in those trials who were treated with brodalumab had skin that was clear or almost clear compared with placebo.

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"Moderate-to-severe plaque psoriasis can cause significant skin irritation and discomfort for patients, and today’s approval provides patients with another treatment option for their psoriasis," said Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. "Patients and their health care providers should discuss the benefits and risks of Siliq before considering treatment."

Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with brodalumab during clinical trials. As such, patients with a history of suicidality or depression may have an increased risk compared with users who do not have a history. A causal relationship between treatment with brodalumab and increased risk of suicidal ideation has not been established.

Brodalumab is also approved with a Medication Guide to inform patients of the risk of suicidal ideation and behavior, and that because brodalumab is a medication that affects the immune system, patients may have a greater risk of getting an infection or an allergic or autoimmune condition.

The most common adverse reactions reported with the use of brodalumab include joint pain (arthralgia), headache, fatigue, diarrhea, throat pain (oropharyngeal pain), nausea, muscle pain (myalgia), injection site reactions, influenza, low white blood cell count (neutropenia) and fungal (tinea) infections.

Brodalumab is marketed by Valeant Pharmaceuticals.--Sean McGuire