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FDA Approves Siliq for Treating Psoriasis

The FDA announced today that it has approved Siliq as treatment for moderate-to-severe plaque psoriasis.

Siliq (brodalumab, Valeant Pharmaceuticals) is administered by injection and is intended for patients who are candidates for systemic therapy or phototherapy and have failed to respond or have stopped responding to other systemic therapies, according to a press release.

Brodalumab binds to a protein that causes inflammation, which inhibits the inflammatory response that is a role in the development of plaque psoriasis.

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

Three randomized, placebo-controlled clinical trials with 4,373 adults with moderate-

to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy were used to establish brodalumab’s safety and efficacy. When compared with placebo, more patients treated with brodalumab had skin that was clear or almost clear, according to scoring mechanisms, the release reported.

The FDA reported that suicidal ideation or behavior, including completed suicides, have occurred in patients treated with brodalumab during clinical trials.

“Siliq users with a history of suicidality or depression had an increased incidence of suicidal ideation and behavior compared to users without this history,” according to the FDA release. “A causal association between treatment with Siliq and an increased risk of suicidal ideation and behavior has not been established.”

The labeling for Siliq includes a boxed warning and the drug is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Siliq REMS Program because of the observed risk of suicidal ideation and behavior, according to the release.

Requirements of the Siliq REMS program include:

Prescribers must be certified with the program and counsel patients about the risk. Patients should be referred to a mental health professional if they have new or worsening symptoms of depression or suicidality, according to the release.

A Patient-Prescriber Agreement Form must be signed by patients, who should be made aware of the need to seek medical attention should they experience new or worsening suicidal thoughts or behavior, depression or anxiety.

Pharmacies also must be certified with the program, and can dispense Silique only to patients who are authorized to receive it.

A medication guide informs patients of the risk of the suicidal ideation and behavior, and that because Siliq affects the immune system, patients may have a greater risk of developing an infection or allergic or autoimmune condition.

Patients with Crohn’s disease are advised not to use Siliq, and health care providers are advised to evaluation patients for tuberculosis infection before initiating Siliq treatment.

Arthalgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia and tinea infections were the most common adverse reactions reported with the use of brodalumab, according to the release.

Reference: www.fda.gov