Valeant announces US launch of Siliq for psoriasis

Valeant Pharmaceuticals International announced the U.S. launch of Siliq injection during the American Academy of Dermatology summer meeting, being held July 27-30 in New York.

The FDA approved Siliq (brodalumab) for treating moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies in February. It is a monoclonal antibody that targets the IL-17 receptor A.

Siliq has a black box warning for suicidal ideation and behavior risks. The product was approved with a risk evaluation and mitigation strategy involving a one-time enrollment for physicians and one-time informed consent for patients, according to a news release.

Brodalumab is contraindicated in patients with Crohn's disease. Caution is urged for patients with a chronic infection or a history of recurrent infection, and patients should be evaluated for tuberculosis infection prior to beginning treatment, according to the release.

Common adverse reactions reported with brodalumab include headache, arthralgia, fatigue, oropharyngeal pain and diarrhea.

"As the first and only IL-17 receptor A blocker, Siliq is the only product on the market that demonstrated 100 percent improvement in the psoriasis area and severity index (PASI 100) during the clinical trials as a primary endpoint,” Lawrence J. Green, MD, assistant clinical professor of Dermatology at George Washington University School of Medicine in Washington, DC, stated in a news release.

Valeant also announced that its dermatology unit will be renamed Ortho Dermatologics, effective immediately, under the new senior leadership team lead by Bill Humphries, executive vice president and company group chairman, Ortho Dermatologics.

"Historically, Ortho Dermatologics was known for high connectivity and partnership with physicians throughout their entire career, and we look forward to continuing to build upon this long-standing legacy,” Humphries stated in the release.

Valeant holds the license to develop and commercialize brodalumab in the US, Canada and other territories, other than Japan and certain other Asian countries, which are held by Kyowa Hakko Kirin Co. Ltd., while LEO Pharma holds exclusive rights to develop and commercialize brodalumab in Europe, according to the release.

Reference: www.valeant.com