Biologics

Genentech BLA Submitted for Satralizumab

FDA has accepted for review a Genentech BLA for satralizumab for treating adults and adolescents with neuromyelitis optica spectrum disorder. The rare, debilitating autoimmune disease of the central nervous system primarily damages the optic nerves and spinal cord, which can cause blindness, muscle weakness and paralysis. Those with the disorder experience unpredictable relapses that can cause permanent neurological damage, according to the company.

The submission is based on positive results from two Phase 3 studies, SAkuraStar and SAkuraSky, that evaluated satralizumab as a monotherapy and in combination with baseline immunosuppressant therapy. In the SAkuraStar study, satralizumab monotherapy achieved a 55% reduction in the risk of relapses compared to placebo, Genentech says. In the SAkuraSky study, combination therapy showed a 62% reduction in the risk of relapses compared to placebo, it adds. Regarding safety, the company says that patients with serious adverse events were similar between the satralizumab and placebo treatment groups in both studies.

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