Drugs

FDA OKs Quality-of-Life Data for Boehringer COPD Drug

FDA has approved a Boehringer Ingelheim Pharmaceuticals supplemental NDA for Stiolto Respimat (tiotropium bromide and olodaterol) that adds to the label data showing improvement in health-related quality of life among people with chronic obstructive pulmonary disease (COPD). Approval is based on data from the OTEMTO 1 and 2 clinical studies, which showed a clinically meaningful improvement in health-related quality of life, as measured by the St. George’s Respiratory Questionnaire (SGRQ) that evaluatied symptoms, activities, and the disease’s impact on daily life.

The drug was originally approved 5/25 as a long-term, once-daily maintenance treatment for airflow obstruction in COPD patients. That approval was based on data from pivotal trials that evaluated more than 5,000 COPD patients and showed it provides statistically significant improvements in lung function (through FEV1 and FEV1 AUC0-3h) at 24 weeks versus tiotropium and olodaterol alone, according to the company. The approved labeling notes that the product is not indicated for asthma and should not be initiated in acutely deteriorating COPD patients or for the relief of acute symptoms.

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