Drugs

aTyr Pharma Reports Mixed Results in Lung Trial

aTyr Pharma is reporting mixed topline results from its Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis, a chronic inflammatory lung disease. While the trial did not meet its primary endpoint, the therapy demonstrated encouraging improvements in quality-of-life measures and steroid reduction, the company says. aTyr said it plans to discuss the results with FDA to determine a regulatory path forward.

The 268-patient study failed to show a statistically significant difference in the primary endpoint of mean daily oral corticosteroid (OCS) reduction at 48 weeks, according to the company. Patients receiving 5.0 mg/kg of efzofitimod reduced their average OCS dose to 2.79 mg compared with 3.52 mg for placebo, it says.

Despite the miss, aTyr says efzofitimod showed potential clinical benefit across several secondary measures, such as 52.6% of patients on the higher dose achieved complete steroid withdrawal, compared with 40.2% on placebo, and patients on 5.0 mg/kg showed greater improvement in King’s Sarcoidosis Questionnaire-Lung scores than placebo. Efzofitimod was well-tolerated, with a safety profile consistent with earlier trials, 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