Drugs

FDA Accepts for Review AstraZeneca Lupus Therapy

FDA has accepted for review AstraZeneca’s anifrolumab, an investigational drug for treating moderate to severe systemic lupus erythematosus (SLE). The agency is expected to make a review decision in the third quarter next year.

The submission was based on data from the two TULIP Phase 3 trials and the MUSE Phase 2 trial, in which the company says a reduction in disease activity and improvement in lupus skin activity were observed with anifrolumab added to standard-of-care therapy compared to placebo and standard-of-care. For example, the Phase 3 TULIP 2 trial met its primary endpoint — “achieving a statistically-significant and clinically-meaningful reduction in disease activity versus placebo.” The reduction, AstraZeneca says, “was measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52. The BICLA requires improvement in all organs with disease activity at baseline with no new flares.”

Anifrolumab is a human monoclonal antibody that binds to subunit 1 of the type I interferon receptor, blocking the activity of all type 1 interferons including IFN-alpha, IFN-beta and IFN-omega, the company says. “Type I interferons are cytokines involved in the inflammatory pathways,” it says. “Between 60% and 80% of adults with SLE have an increased type I interferon gene signature, which has been shown to correlate with disease activity.”

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