Psoriasis has once again been put to the spotlight following after the US FDA's approval of an injectable biologic called brodalumab or also known as Siliq, by Valeant Pharmaceuticals, which is an injectable drug that has well been regarded as treatment for adults with moderate-to-severe psoriasis. However, along with FDA's approval of brodalumab, authorities say that it also comes with important yellow flags. Consequently, it was also found that the FDA has allegedly ordered a boxed label warning on an observed risk for suicidal thoughts and actions with brodalumab.
Brodalumab For Psoriasis
According to reports revealed by the US Food And Drug Administration, Siliq is allegedly intended for those types of patients who are candidates for systemic therapy treatment that mainly uses various substances that travel through the bloodstream, after being taken by mouth or injected or phototherapy which is also referred to as ultraviolet light treatment and have failed to respond, or have stopped responding to other systemic therapies. Additionally, the FDA reveals that the drug will be only be available through a Risk Evaluation and Mitigation Strategy (REMS) program that focuses on restricting those who can receive the drug.
Furthermore, as per Medscape, the drug's manufacturer has reported a total of six suicides in nearly 6200 patients who are said to be taking brodalumab in six trials. Consequently, four of these patients were on the process of being treated for psoriasis and one apiece for rheumatoid arthritis and psoriatic arthritis. On the other hand, the US FDA has already explained that a causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established.
The US FDA On Psoriasis And Brodalumab
In one of her statements, Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research said that moderate-to-severe plaque psoriasis can cause significant skin irritation and discomfort for patients, and today's approval provides patients with another treatment option for their psoriasis. Long before, psoriasis has been regarded as 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 15 and 35. Ultimately, experts reveal that Siliq's active ingredient (brodalumab) allegedly binds to a protein that causes inflammation, which, in turn, inhibits the inflammatory response that plays a vital role in the development of plaque psoriasis.