Biologics

FDA Accepts Roche sBLA for Gazyva in Lupus

FDA has accepted a Roche supplemental BLA that seeks to expand use of Gazyva to treat Systemic Lupus Erythematosus (SLE). The agency is expected to make a decision by December. If approved, Gazyva, which is already approved for lupus nephritis, could become the first anti-CD20 therapy specifically indicated for SLE, directly targeting B cells involved in disease activity.

The filing is based on results from the Phase 3 ALLEGORY trial, which demonstrated statistically significant and clinically meaningful improvements in disease activity compared with placebo, according to the company. At 52 weeks, 76.7% of patients receiving Gazyva plus standard therapy achieved at least a four-point improvement on the SLE Responder Index, compared with 53.5% in the placebo group. The study also showed benefits across multiple secondary endpoints, including higher remission rates and reduced disease flares.

Patients treated with the drug were less likely to experience flares — a key driver of long-term organ damage — and more than twice as likely to achieve clinical remission compared with those receiving standard therapy alone, according to the company. Safety findings were consistent with the drug’s established profile, with no new safety signals identified, it 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

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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