Drugs

Roche Reports Mixed Data on COPD Studies

Roche says its investigational chronic obstructive pulmonary disease (COPD) drug astegolimab showed mixed results in two key late-stage clinical trials evaluating its effectiveness in reducing patient exacerbations in those with moderate to very severe chronic conditions.

The company’s Phase 2B ALIENTO trial met its primary endpoint, with astegolimab demonstrating a statistically significant 15.4% reduction in the annualized exacerbation rate (AER) over 52 weeks compared to placebo, when administered every two weeks alongside standard-of-care maintenance therapy. However, the larger Phase 3 ARNASA trial failed to meet its primary endpoint, showing a 14.5% reduction in AER that did not reach statistical significance, the company says.

Despite the difference in primary outcomes, Roche says results across secondary endpoints were generally consistent between the two studies, and the overall number of exacerbations was lower than expected in both trials, which may have impacted statistical power. The safety profile of astegolimab remained in line with previous data, and no new safety concerns were identified, it says.

Roche plans to engage with regulatory authorities to determine the appropriate next steps for astegolimab, adding that full results from both studies will be presented at an upcoming medical conference.

Astegolimab is described as a monoclonal antibody that targets the ST2 receptor, aiming to block IL-33 signaling, a pathway thought to affect airway inflammation.

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