Drugs

Lilly’s Taltz OK’d for Ankylosing Spondylitis

FDA has approved Eli Lilly’s Taltz (ixekizumab) injection 80 mg/mL for treating adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis. The drug was initially approved 3/2016 for treating moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. It was subsequently approved in 12/2017 for treating adults with active psoriatic arthritis.

The latest approval is based on data from two randomized, double-blind, placebo-controlled Phase 3 studies that included 657 adult patients with active AS: COAST-V in patients who are biologic disease-modifying antirheumatic drug-naïve and COAST-W in patients who previously had an inadequate response or were intolerant to tumor necrosis factor inhibitors. “Results from both studies demonstrated that patients treated with Taltz achieved statistically significant and clinically meaningful improvements in signs and symptoms compared to placebo, the company says.

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

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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