Drugs

FDA Approves Valeant Pharma NDA for Psoriasis Drug

FDA has approved a Valeant Pharmaceuticals NDA for Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is intended for patients who are systemic therapy or phototherapy candidates who have failed to respond, or have stopped responding to other systemic therapies, an agency news release says. Brodalumab works by binding to a protein that causes inflammation, inhibiting the inflammatory response that plays a role in the development of plaque psoriasis, FDA says.

Approval is based on data from three randomized, placebo-controlled clinical trials involving 4,373 adult participants with moderate-to-severe plaque psoriasis. “More patients treated with Siliq compared to placebo had skin that was clear or almost clear, as assessed by scoring of the extent, nature and severity of psoriatic changes of the skin,” FDA says.

A Boxed Warning and a Risk Evaluation and Mitigation Strategy restricted-distribution program are required to address suicidal ideation and behavior risks. “Siliq users with a history of suicidality or depression had an increased incidence of suicidal ideation and behavior compared to users without this history,” says. “A causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome