Brodalumab, an injectable biologic from Valiant Pharmaceuticals, has recently been approved by the US Food and Drug Administration (FDA). The drug, which comes with some notable yellow flags, is to be used to treat moderate to severe psoriasis in adults.
Stipulations of Approval
The label on the box, ordered as a stipulation of approval by the FDA, warns of an increased risk of suicidal actions and thoughts. In addition, a thorough Risk Evaluation and Mitigation Strategy (REMS) will be required before anyone can be prescribed the drug.
Only those who have not responded or are no longer responding to phototherapy and systemic therapy can be indicated as potential recipients of Brodalum. Administering the drug ensures the inflammatory response responsible for psoriasis is blocked, by inhibiting the interleukin-17 receptor A.
An 18-0 decision in favour or approving Brodalumab was reached by the FDA advisory panel in July 2016. However, the majority of members also called for the warning labels and a REMS programme.
Clinical Trial Data
Clinical trial services, similar to those provided by http://www.gandlscientific.com/clinical-trial-services/, reported six suicides out of 6,200 patients who were being prescribed Brodalumab. This was over the course of six trials. Out of these, one was being treated for psoriatic arthritis, one for rheumatoid arthritis and four for psoriasis.
Regarding the instances of suicide within the clinical trials, the FDA stated in a press release that these were higher in those patients who already had a history or depression or suicidal behaviours. As a result, it has not been possible to establish any causal relationship between these suicides and the drug.
In order to prescribe the drug, however, clinicians and pharmacists must be REMS programme certified and must also counsel their patients regarding the possible increased risk of suicidal tendencies. A mental health professional must become involved if patients in receipt of the drug suffer the onset of or increase in suicidality or depression.
4,373 patients suffering from psoriasis and involved in clinical trials found Brodalumab to be effective in the treatment of the condition, which was a higher number than that reported in the placebo group.
Some other adverse side effects were observed during the trials, which included throat pain, diarrhoea, fatigue, headaches and joint pain.