FDA approves Valeant plaque psoriasis drug despite suicide concerns
The US Food and Drug Administration (FDA) has announced that it has approved Valeant Pharmaceutical’s injectable psoriasis treatment Siliq (brodalumab) for use in the United States, despite earlier concerns over risks it could pose to patients.
Siliq has been given the green light to treat adult patients suffering from moderate to severe plaque psoriasis whom are also candidates for systemic therapy or phototherapy and have failed to respond to other systemic therapies.
The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously for the administration to approve the drug back in July last year; it has been approved despite concerns that its use in patients led to potential risk of suicidal ideation and self-injurious behaviour in clinical trials, due to its significant efficacy in an area of unmet need.
Due to these concerns, Siliq is only available through a restricted access programme under a Risk Evaluation and Mitigation Strategy (REMS) and carries a Boxed Warning on the label as well as a Medication Guide to inform patients of the risks of using the drug. It is also noted that the drug should not be used in patients with active tuberculosis infection, and healthcare providers should evaluate patients for the disease before administering the drug.
Julie Beitz, Director of the Office of Drug Evaluation III at the FDA’s Center for Drug Evaluation and Research commented on the approval: “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. Patients and their healthcare providers should discuss the benefits and risks of Siliq before considering treatment.”
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