Drugs

AbbVie NDA for Uterine Fibroid Bleeding

AbbVie has submitted an NDA for elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist with a proposed indication for managing heavy menstrual bleeding (HMB) associated with uterine fibroids. The submission is based on data from the elagolix Phase 3 uterine fibroid program, which evaluated nearly 800 premenopausal women with uterine fibroid-associated HMB in two pivotal studies (ELARIS UF-I and ELARIS UF-II) at about 100 sites in the U.S. and Canada. The primary endpoint assessed the reduction in HMB compared to placebo as measured by the alkaline hematin method, an objective measurement of total menstrual blood loss.

The company says that in ELARIS UF-1, 68.5% of women with uterine fibroids achieved a clinical response compared to placebo (8.7%). In ELARIS UF-2, 76.2% of women with uterine fibroids achieved aclinical response compared to placebo (10.1%). “In both studies, clinical response was defined as menstrual blood loss volume of less than 80 mL during final month and a 50% or greater reduction in menstrual blood loss volume from baseline to final month,” AbbVie says.

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