Drugs

FDA Breakthrough Designation for Actemra/RoActemra

FDA has granted Breakthrough Therapy designation to Roche’s Actemra/RoActemra (tocilizumab) for giant cell arteritis (GCA), described as a chronic, potentially life-threatening autoimmune condition. The company says the disease is caused by inflammation of large and medium-sized arteries, most often in the head but also in the aorta and its branches.

Earlier this year Roche released results of the Phase 3 GiACTA trial evaluating Actemra/RoActemra in people with GCA. Results showed that the treatment, combined with a six-month steroid regimen, more effectively sustained remission through one year, compared to a six- or 12-month steroid-only regimen, the company says.

Actemra/RoActemra is described as the only approved anti-IL-6 receptor biologic, available in both intravenous and subcutaneous formulations, for treating adult patients with moderate to severe active rheumatoid arthritis. It can be used alone or with methotrexate in adults who are intolerant to or have failed to respond to other anti-rheumatic medications. It is being investigated in a global Phase 3 study for patients with systemic sclerosis. FDA granted it Breakthrough Therapy designation for that indication in 2015.

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