A new drug to treat moderate-to-severe plaque psoriasis carries a black box warning that suicidal ideas and behavior, including completed suicides, have occurred in patients during the drug’s clinical trials.
While FDA recently approved Siliq (Valeant Pharmaceuticals), the agency said the drug is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Siliq REMS Program. Prescribers must be certified with the program and counsel patients about this risk. Pharmacies must also be certified with the program and can only dispense Siliq to patients who are authorized to receive it.
In addiiton, patients must sign a Patient-Prescriber Agreement Form and be made aware of the need to seek medical attention should they experience new or worsening suicidal thoughts or behavior, feelings of depression, anxiety or other mood changes.
Valeant plans to start marketing the drug in the second half of 2017.
Siliq is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected) or phototherapy (ultraviolet light treatment) and have failed to respond, or have stopped responding to other systemic therapies.
"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, in a FDA statement. "Patients and their health care providers should discuss the benefits and risks of Siliq before considering treatment."
Siliq’s safety and efficacy were established in 3 randomized, placebo-controlled clinical trials with a total of 4,373 adult participants with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy. More patients treated with Siliq compared to placebo had skin that was clear or almost clear.
The most common adverse reactions reported with the use of Siliq 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.
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