Biologics

FDA Priority Review for Genentech Actemra sBLA

FDA has accepted for priority review a Genentech supplemental BLA for Actemra (tocilizumab) for treating giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition. The submission is based on “positive outcome” data from a Phase 3 called GiACTA that evaluated Actemra in people with GCA, according to the company. “Results showed that Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six- or 12-month steroid taper regimen given alone in people with GCA,” it says.

GCA affects about 200 per 100,000 persons in the U.S. over the age of 50, and the disease is two to three times more likely to affect women than men, Genentech says. It is often difficult to diagnose because of the wide and variable spectrum of signs and symptoms. The condition causes severe headaches, jaw pain and visual symptoms and if left untreated, can lead to blindness, aortic aneurysm or stroke. Treatment to date for people with GCA has been limited to high-dose steroids as an “emergency” treatment option to prevent damage such as vision loss, the company says.

Actemra is a humanized interleukin-6 receptor antagonist approved for treating adult patients with moderately to severely active rheumatoid arthritis who have used one or more disease-modifying antirheumatic drugs, such as methotrexate, that did not provide enough relief.

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