Psoriasis patients now have hope of treatment following the United States Food and Drug Administration’s approval of its drug Siliq. Valeant Pharmaceuticals Intl Inc (NYSE:VRX) developed the drug Siliq, otherwise known as Brodalumab, to treat adult patients with plaque psoriasis either in moderate or severe states. The drug is administered as an injection.
The drug is administered to patients on systematic therapy treatment. This is a type of treatment whereby the substances ingested or injected travel up the bloodstream. It is also administered to patients undergoing ultraviolet light treatment with no response.
Julie Beitz, Medical Doctor and director at the Office of Drug Evaluation in the FDA reveals that moderate or severe plaque can cause irritation of the skin and distress for its patients. The drug approval has provided these patients with a treatment alternative for psoriasis. However, patients should consult with their care givers before commencing treatment with Siliq to ascertain health risks and benefits.
Psoriasis is a skin defect that causes reddening and flaking of the skin that is common in patients who have a hereditary history of the disease. It is an autoimmune condition that begins to manifest in people who are aged in mid-teens to early adulthood. The prevelant form of the disease is plaque psoriasis.
The active ingredients contained in Siliq latches on to a protein in psoriasis that causes inflammation, inhibiting the same. Three random placebo-controlled trials were performed to determine the drug’s efficiency and safety. This involved a total of 4,373 participants, all adults, with different levels of plaque psoriasis and all of whom were systemic therapy and phototherapy candidates. Those who received treatment with Siliq had clear to almost clear skin compared to the placebos.
However, Siliq users in the trial manifested suicidal thoughts and behavior as opposed to the placebo treatments, therefore, because of this risk, Siliq labelling includes a warning. The warning states that the drug is available only through a regulated program that is approve by a risk evaluation program. Reported side effects or adverse reactions with the use of Siliq include joint pain, fatigue, headaches, diarrhea, nausea, throat pain, muscle pain, reactions on injection sites, a low count white-blood cell count, fungal infections and influenza.
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The most prevelant adverse reactions observed with the use of Siliq include headache, fatigue, joint pain (arthralgia), throat pain (oropharyngeal pain), muscle pain (myalgia), diarrhea, nausea, influenza, injection site reactions, fungal (tinea) infections and low white blood cell count (neutropenia).
