FDA Approves Siliq for Plaque Psoriasis

The FDA yesterday approved brodalumab (Siliq) to treat adults with moderate-to-severe plaque psoriasis.

The approval was based on results from 3 randomized, placebo-controlled clinical trials, which included a total of 4373 adults with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy, according to a press release.

The results of the studies showed that more patients administered brodalumab achieved clear or almost clear skin compared with placebo. The skin of the participants was assessed by scoring the extent, nature, and severity of psoriatic changes of the skin.

Plaque psoriasis is the most common form of psoriasis, and causes patients to develop thick, red skin with flaky, silver-white scales.

“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.”

The active ingredient brodalumab binds to a protein that causes inflammation, preventing an inflammatory response that plays a role in the development of plaque psoriasis.

The most common adverse events reported for brodalumab include joint pain, headache, fatigue, diarrhea, throat pain, nausea, muscle pain, injection site reactions, influenza, low white blood cell count, and fungal infections.

During clinical trials, some patients experienced suicidal ideation and behavior, including complete suicides. Patients who received brodalumab and who had a history of suicidality or depression, were found to have an increased incidence of suicidal ideation and behavior compared with users without this history.

The causal association between treatment with brodalumab and increased risk of suicidal ideation and behavior has not been established, according to the release.

Due to the observed risk of suicidal ideation and behavior, the FDA required brodalumab’s labeling to include a Boxed Warning. Furthermore, the drug is only available through a restricted program under a Risk Evaluation and Mitigation Strategy called the Siliq REMS Program.

Requirements of the Siliq REMS Program include: prescribers must be certified with the program and counsel patients about the risk. Patients with new or worsening symptoms of depression or suicidality should be referred to a mental health professional; patients must sign a Patient-Prescriber Agreement Form and be made aware of seeking medical attention if they experience new or worsening suicidal thoughts or behavior, depression, anxiety, or other mood changes; and pharmacies must be certified with the program, and must only dispense the drug to patients authorized to receive brodalumab.