FDA Approves Siliq for the Treatment of Plaque Psoriasis
The Food and Drug Administration (FDA) has approved Siliq (brodalumab injection; Valeant) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and who have failed to respond or have lost response to other systemic therapies.
Brodalumab is a human monoclonal IgG2 antibody that selectively binds to human interleukin-17 (IL-17) receptor A and inhibits inflammatory signaling by preventing the binding of several types of IL-17 to the receptor.
The safety and efficacy of Siliq was established in three, randomized, placebo-controlled trials in a total of 4,373 patients with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy. Compared to placebo, more patients treated with Siliq had skin that was clear or almost clear, as assessed by scoring of the extent, nature, and severity of psoriatic changes of the skin.
"Siliq is the only product that has demonstrated 100% improvement in the psoriasis area and severity index (PASI 100) during clinical trials as a primary endpoint," said Lawrence J. Green, M.D., associate clinical professor of Dermatology at George Washington University School of Medicine in Washington, D.C. "As the first IL-17 receptor A blocker that helps stop the proinflammatory cascade that leads to psoriasis, resulting in the normalization of skin inflammation, this is a significant achievement for the many patients who suffer with moderate-to-severe plaque psoriasis. “
The prescribing information for Siliq includes a Black Box Warning indicating that suicidal ideation and behavior have occurred in some patients, and that the risk of this occurring should be weighed against the benefits particularly in patients with a history of depression and/or suicidal ideation or behavior. Because of the observed suicidal behaviors, Siliq is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called Siliq REMS Program.
Some of requirements of the REMS include:
- 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 other mood changes.
- Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive Siliq.
In addition, Siliq is contraindicated in patients with Crohn's disease, as the drug may cause worsening of the disease.
The most common adverse effects associated with Siliq include arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinea infections.
Siliq will be supplied as a 210mg/1.5mL single-dose prefilled syringe. The company expects to make the product available in the second half of 2017.
For more information visit Valeant.com.