(Reuters)—The U.S. Food and Drug Administration has approved Valeant Pharmaceuticals International Inc.’s brodalumab (Siliq) to treat adults with moderate to severe plaque psoriasis. Brodalumab is administered as an injection. Brodalumab is intended for patients who are candidates for systemic therapy or phototherapy and have failed to respond, or have stopped responding to other systemic therapies,…
NEW YORK (Reuters Health)—Psoriasis patients treated with tumor necrosis factor-alpha (TNF) inhibitors may have a lower risk of major cardiovascular (CV) events than those treated with methotrexate (MTX), according to a new study. “The findings do not surprise me. TNF inhibitors control inflammation better than methotrexate,” lead author Dr. Jashin J. Wu of Kaiser Permanente…
Due to manufacturing deficiencies found during a routine inspection by the FDA, approval of sarilumab for treating RA has slowed until facility issues are resolved…
(Reuters Health)—People with psoriasis may be at increased risk of coronary artery calcium buildup, comparable to that of people with diabetes, according to a new study. Comparing people in their 50s with psoriasis, diabetes or neither disease, researchers found that moderate to severe calcium buildup was about five times as common in people with diabetes…
In three clinical trials, ixekizumab proved more effective than placebo or etanercept at increasing the work attendance and productivity of patients with plaque psoriasis…
(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide, an advisory committee to the U.S. Food and Drug Administration concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory committees but typically…
n clinical trials, tildrakizumab was more effective than etanercept and placebo at treating moderate to severe plaque psoriasis. Adalimumab has received approval for treating non-infectious intermediate, posterior and panuveitis—its 10th FDA indication…
(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said on Friday. The review comes two days ahead of a meeting of outside experts who will advise the FDA on…