Brodalumab approved for psoriasis with REMS required.
THE FOOD AND DRUG Administration has approved brodalumab, an interleukin-17 receptor A-antagonist, for treating adults with moderate to severe plaque psoriasis, with a Risk Evaluation and Mitigation Strategy (REMS) that addresses the "observed risk of suicidal ideation and behavior" in clinical trials, the agency announced on Feb. 16.
In the three pivotal phase III studies of 4,373 adults with moderate to severe plaque psoriasis who were candidates for systemic therapy or phototherapy, 83%-86% of those treated with brodalumab achieved Psoriasis Area and Severity Index (PASI 75) scores at 12 weeks of treatment, compared with 3%-8% of those on placebo. In addition, 37%-44% of those on brodalumab achieved PASI 100 scores, compared with 1% or fewer of those on placebo. In the psoriasis clinical trials, suicidal ideation and behavior, which included four completed suicides, occurred in patients treated with brodalumab, according to the prescribing information
Brodalumab will be marketed as Siliq, by Valeant Pharmaceuticals.
In the statement, the FDA points out that "a causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established," but that "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 with users without this history."
At a meeting in July 2016, the FDAs Dermatologic and Ophthalmic Drugs Advisory Committee voted 18-0 in favor of approving brodalumab, with the majority (14) recommending risk management options beyond labeling to address these concerns.
Elements of the REMS include requirements for prescribers and pharmacy certification, and a medication guide for patients with information about the risks of suicidal ideation and behavior. Prescribers are required to counsel patients about this risk, and patients are required to 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," the FDA said. The prescribing information also includes a boxed warning about suicidal ideation and behavior.
The most common adverse events associated widi brodalumab, the FDA statement noted, include arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, neutropenia, and fungal infections. The recommended dose of brodalumab is 210 mg, administered subcutaneously at weeks 0,1, and 2, followed by 210 mg every 2 weeks.
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|Date:||Mar 1, 2017|
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