The FDA has just released an official announcement that made public its decision to approve a new psoriasis drug for the public. Psoriasis is an autoimmune disease that affects the body through abnormal patches on the skin. The new treatment uses brodalumab which is actually a monoclonal antibody extracted from humans and altered to treat inflammatory diseases. The drug has been waiting for a year the approval from the U.S. Food and Drug Administration.
On Thursday, FDA announced its approval for the Siliq drug which is an injectable treatment from Valeant Pharmaceuticals for mild to severe psoriasis. The new drug is introduced on the market just as a last resort for adult patients that see no results from other recommended treatments. Moreover, the new psoriasis drug will be labeled with a warning sign that notifies patients on the risk to develop suicidal behavior.
Dr. Julie Beitz at FDA explains their approval of the new treatment from Valeant as yet another option for patients to relief the discomfort their condition caused. This disease develops in persons aged 15 to 35, and its advanced forms can cause extreme physical discomfort. They may be sleep deprived due to itchiness and pain. This autoimmune condition is often linked to low-self esteem image as patients experience visible signs on their skin. Some studies associated psoriasis with depression and even thoughts of suicide.
The FDA adjusted its approval so that only certain patients are eligible for the new psoriasis drug. Thus, those who want the new treatment have to confirm that they were candidates for a series of other treatments as well. These are the systemic therapy that works with pills or injectable substances in their bloodstream, and phototherapy which is a form of treatment through ultraviolet light. If patients didn’t experience any alleviation of their condition through these therapies, they are entitled to request the new drug.
Siliq received the approval after conducting a series of three studies in which were involved more than 4,300 patients. Those patients who didn’t take the placebo pill ended up having clear or almost clear skin. To receive such a drug, patients have to go through a suicide risk evaluation program.
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