The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee recently unanimously voted for the approval of Siliq (brodalumab), a Valeant Pharmaceuticals drug for psoriasis. Full FDA approval is expected to be decided before December this year.
Siliq, recently approved in Japan, has shown to be highly effective and beneficial in clinical trials, leading committee opinions to approve the drug, despite potential side effects.
The most concerning risks are possible side effects that may lead to suicide or self-injurious behaviors. Of the total 6,200 participants, involving all studies, six suicides were reported. This rate of suicide is higher than what’s typically observed in psychiatric drug clinical trials, provoking debate within the committee.
Dr. Elaine Morrato, associate professor of health systems, management and policy at the Colorado School of Public Health and Advisory Committee member, disclosed that there still remains a significant unmet medical need, speaking to the state of research in psoriasis.
Although these risks are significant, it’s important to note that depression and suicide are more frequent in patients with psoriasis. Before the trials, 7 percent of participants had psychiatric disorders and 23 percent had moderate to severe anxiety or depression.
The committee agreed in unanimous favor that the benefits outweighed the risks.