Valeants Brodalumab FDA Approved for Psoriasis Save

FDA has approvesd the IL-17 targeted therapy Siliq (brodalumab) for moderate-severe plaque psoriasis.

The drug was originally developed by Amgen and Astra-Zenica but they abandoned its development with concerns about depression and risk of suicide.  The agent was purchased by Valeant and brought to market, but not without some concernes.  Notably the agent comes with a black box warning for suicide.

Siliq’s safety and efficacy were established in three 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, as assessed by scoring of the extent, nature and severity of psoriatic changes of the skin.

Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with Siliq 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. A causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established.

Because of the observed risk of suicidal ideation and behavior, the labeling for Siliq includes a Boxed Warning and the drug is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Siliq REMS Program. Notable requirements of the Siliq REMS Program include the following:

• Prescribers must be certified with the program and counsel patients about this risk. Patients with new or worsening symptoms of depression or suicidality should be referred to a mental health professional, as appropriate.
• 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 othernts who are authorized to receive Siliq.
• Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive Siliq.