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Update: FDA Panel Supports Approval Of Valeant’s Psoriasis Drug With Risk Management

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FDA

While the FDA has not officially approved the drug, the agency usually follows the advice of the advisory panel.

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Tweet: #FDA: Valeant’s #psoriasis drug should be approved, along with measures designed to reduce the risk of suicide http://ctt.ec/37Kef+FDA: Valeant’s psoriasis drug should be approved, along with measures designed to reduce the risk of suicide.

Tweet: Valeant has proposed a risk management registry for #psoriasis drug, but is not in favour of a boxed warning http://ctt.ec/IJu30+Valeant has proposed a risk management registry for psoriasis drug, but is not in favour of a boxed warning.

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July 21, 2016 | by Sarah Massey, M.Sc.

An advisory committee to the US Food and Drug Administration (FDA) has concluded that Valeant Pharmaceuticals’ experimental psoriasis drug should be approved, along with measures designed to reduce the risk of suicide. While the FDA has not officially approved the drug, the agency usually follows the advice of the advisory panel.

In all, six patients committed suicide across multiple clinical trials for the psoriasis drug, brodalumab. Four of the suicides took place during psoriasis clinical trials, with one in a psoriatic arthritis study and one in a rheumatoid arthritis study. Despite the deaths, the FDA advisory committee voted unanimously to approve the drug.

The majority of panel members voted that the drug should be prescribed in conjunction with a suicide risk management program. This program could include communications plans for healthcare providers as well as medication guides.



The advisory panel noted that the risks of brodalumab were outweighed by the potential benefits of the drug, which could offer a new treatment option for psoriasis sufferers. A boxed warning and a patient data registry were also proposed as ways to mitigate the suicide risk.

While some thought the registry should be mandatory for all patients, other members were concerned that this could create barriers to patient access to the drug. Valeant has proposed a risk management registry, but is not in favour of a boxed warning.

Brodalumab is an interleukin-17 receptor antagonist, designed to reduce inflammation. Novartis’ Cosentyx and Eli Lilly’s Taltz, are currently available drugs from this class.

According to the American Academy of Dermatology, approximately 7.5 million US citizens suffer from psoriasis. The autoimmune disease is characterized by scaly patches of dry skin, which sometimes occurs in people with diabetes and heart disease.


Keywords: FDA, Psoriasis, Boxed Warning


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