The US Food and Drug Administration (FDA) today approved an injectable biologic called brodalumab (Siliq, Valeant Pharmaceuticals) to treat adults with moderate-to-severe psoriasis, but the approval comes with important yellow flags.
The agency ordered a boxed label warning on an observed risk for suicidal thoughts and actions with brodalumab. In addition, the drug will be available only through a Risk Evaluation and Mitigation Strategy (REMS) program that will restrict who can receive the drug.
Brodalumab is indicated for patients who are candidates for systemic therapy or phototherapy who have failed to respond, or stopped responding, to other systemic therapies. The drug inhibits the interleukin-17 receptor A, thereby blocking the inflammatory response involved in plaque psoriasis.
In July 2016, an FDA advisory panel voted 18-0 to recommend approval of brodalumab, but most of its members favored a strong warning about the potential for suicide and self-injurious behavior along with a REMS program based on clinical trials.
The drug's manufacturer reported six suicides in roughly 6200 patients taking brodalumab in six trials — four of the patients were being treated for psoriasis and one apiece for rheumatoid arthritis and psoriatic arthritis.
In a news release, the FDA stated that the incidence of suicide ideation and behavior in the clinical trials was higher among patients who had a history of suicidality or depression. "A causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established," the agency said.
Clinicians must be certified with the REMS program to prescribe the drug, and they must counsel patients about the possible suicide risk. When patients taking the drug experience new or worsening depression or suicidality, they must be referred to a mental health professional. Only REMS-certified pharmacies can dispense the drug, and only to authorized patients.
The FDA determined that brodalumab was effective based on clinical trials involving 4373 patients with psoriasis. More patients treated with brodalumab had skin that was clear, or almost clear, of red patches and flaking than those treated with a placebo.
Joint pain, headache, fatigue, diarrhea, and throat pain numbered among the most adverse events observed in the clinical trials.
More information about today's decision is available on the FDA website.