Drugs

Dupixent Approved for COPD Add On

FDA has approved Sanofi and Regeneron’s Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

Approval is based on data from two landmark pivotal Phase 3 studies (BOREAS and NOTUS) that evaluated the efficacy and safety of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled, according to the companies. They say that patients in the studies who received Dupixent saw the following:

30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations at Week 52, the primary endpoint
74mL and 68mL improvements in post-bronchodilator forced expiratory volume (FEV1) from baseline at Week 12 compared to placebo
51% response in health-related quality of life measures in both trials compared to 43% and 47% with placebo at Week 52

Monoclonal antibody Dupixent works by inhibiting the signaling of the IL-4 and IL-13 pathways, according to the companies. It’s currently approved for treating atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and prurigo nodularis.

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