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FDA Approves New Psoriasis Drug
The FDA has given the green light to brodalumab (Siliq, Valeant Pharmaceuticals) for the treatment of adults with moderate-to-severe plaque psoriasis. Brodalumab is intended for patients who are candidates for systemic therapy or phototherapy and have failed to respond or have stopped responding to other systemic therapies. The drug is administered by injection.
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 15 and 35 years of age. The most common form of psoriasis is plaque psoriasis, in which patients develop thick, red skin with flaky, silver-white scales.
Brodalumab binds to a protein that causes inflammation, thereby inhibiting the inflammatory response that plays a role in the development of plaque psoriasis.
The efficacy and safety of brodalumab were established in three randomized, placebo-controlled trials involving a total of 4,373 adults with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy. More patients treated with brodalumab had skin that was rated “clear” or “almost clear” compared with placebo-treated subjects.
Suicidal ideation and behavior, including completed suicides, have occurred in subjects treated with brodalumab during clinical trials. Brodalumab users with a history of suicidality or depression had an increased incidence of suicidal ideation and behavior compared with users without this history. A causal association between treatment with brodalumab and an increased risk of suicidal ideation and behavior has not been established.
Because of the observed risk of suicidal ideation and behavior, the labeling for brodalumab includes a boxed warning, and the drug is available only through a restricted program under a risk evaluation and mitigation strategy (REMS).
The most common adverse events reported with the use of brodalumab include arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection-site reactions, influenza, neutropenia, and fungal infections.
Source: FDA; February 15, 2017.