"The U.S. Food and Drug Administration today approved Siliq brodalumab to treat adults with moderatetosevere plaque psoriasis. Siliq is administered as an injection. Siliq is intended for patients who are candidates for systemic therapy treatment using substances that travel through the bloodstream after being taken by mouth or injected or phototherapy ultraviolet light treatment and have failed to respond or have stopped responding to other systemic therapies.  Moderatetosevere plaque psoriasis can cause significant skin irritation and discomfort for patients and todays approval provides patients with another treatment option for their psoriasis said Julie Beitz M.D. director of the Office of Drug Evaluation III in the FDAs Center for Drug Evaluation and Research. Patients and their health care providers should discuss the benefits and risks of Siliq before considering treatment. Psoriasis is a skin condition that causes patches of skin redness and flaking. Psoriasis is an autoimmune disorder that occurs more commonly in patients with a family history of the disease and most often begins in people between the ages of  and . The most common form of psoriasis is plaque psoriasis in which patients develop thick red skin with flaky silverwhite scales httpsmedlineplus.govencyarticle.htm. Siliqs active ingredient brodalumab binds to a protein that causes inflammation inhibiting the inflammatory response that plays a role in the development of plaque psoriasis. Siliqs safety and efficacy were established in three randomized placebocontrolled clinical trials with a total of  adult participants with moderatetosevere 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 PatientPrescriber 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. Siliq is also approved with a Medication Guide to inform patients of the risk of suicidal ideation and behavior and that because Siliq is a medication that affects the immune system patients may have a greater risk of getting an infection or an allergic or autoimmune condition. Patients with Crohns disease should not use Siliq. Health care providers should also evaluate patients for tuberculosis TB infection prior to initiating treatment with Siliq. Health care providers should not administer Siliq to patients with active TB infection and should avoid immunizations with live vaccines in patients being treated with Siliq. The most common adverse reactions reported with the use of Siliq include joint pain arthralgia headache fatigue diarrhea throat pain oropharyngeal pain nausea muscle pain myalgia injection site reactions influenza low white blood cell count neutropenia and fungal tinea infections. Siliq is marketed by Bridgewater New Jerseybased Valeant Pharmaceuticals. The FDA an agency within the U.S. Department of Health and Human Services protects the public health by assuring the safety effectiveness and security of human and veterinary drugs vaccines and other biological products for human use and medical devices. The Agency also is responsible for the safety and security of our nations food supply cosmetics dietary supplements products that give off electronic radiation and for regulating tobacco products."