The drug is being marketed as the cheapest injectable psoriasis treatment available in the US.
Following approval by the US Food and Drug Administration (FDA) in February and European Union clearance in July, Valeant Pharmaceuticals is announcing the launch of its brodalumab (SILIQ) injection for the treatment of plaque psoriasis in the US.
The drug is a monoclonal antibody that targets the IL-17 receptor A and inhibits inflammatory signaling by preventing the binding of several types of IL-17 to the receptor. It is indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy, and have failed to respond or have lost response to other systemic therapies, according to a Valeant statement.
“With the availability of SILIQ, physicians have a novel, efficacious treatment option for their adult patients who suffer from moderate-to-severe plaque psoriasis, which can be a truly debilitating, incurable condition,” said Joseph C Papa, Valeant CEO and chairman.
Valeant is marketing SILIQ as the lowest-priced injectable biologic psoriasis treatment in the US, and claims it is the only product on the market that demonstrated 100% improvement in the psoriasis area and severity index (PASI 100) during clinical trials.
“In the 3 clinical trials that have been completed, more than 50% of patients who used SILIQ achieved total skin clearance within a year,” said Lawrence J Green, MD, assistant clinical professor of dermatology at George Washington University School of Medicine in Washington, DC.
The drug contains a Black Box Warning for risks of suicidal ideation and behavior. It was approved with a Risk Evaluation and Mitigation Strategy (REMS) involving a one-time enrollment for physicians and a one-time informed consent for patients.
Common adverse events include headache, arthralgia, fatigure, oropharyngeal pain and diarrhea. SILIQ is contraindicated in patients with Crohn’s disease.
SILIQ’s initial approval was based on findings from three randomized trials that explored the drug across 4373 patients with moderate-to-severe plaque psoriasis.
In the trials, SILIQ was explored at a 210 mg and 140 mg dose compared with either placebo or ustekinumab. In the 210-mg arm, 83.3% to 85.1% of patients had at least a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at 12 weeks.