Drugs

Lilly’s Taltz Approved for Plaque Psoriasis

FDA has approved an Eli Lilly NDA for Taltz (ixekizumab), indicated for treating adults with moderate-to-severe plaque psoriasis. The drug works by binding to a protein (interleukin (IL)-17A) that causes inflammation. “By binding to the protein, ixekizumab is able to inhibit the inflammatory response that plays a role in the development of plaque psoriasis,” an FDA release says.

Approval was based on safety and efficacy data from clinical trials with a total of 3,866 participants with plaque psoriasis who were candidates for systemic therapy or phototherapy. “The results showed that Taltz achieved greater clinical response than placebo, with skin that was clear or almost clear, as assessed by scoring of the extent, nature and severity of psoriatic changes of the skin,” the agency says.

Because Taltz affects the immune system, a Medication Guide is required to inform patients that they may have a greater risk of an infection, or an allergic or autoimmune condition. “Serious allergic reactions and development or worsening of inflammatory bowel disease have been reported with the use of Taltz,” FDA adds.

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