Drugs

AbbVie Elagolix NDA Review Extended 3 Months

FDA has told AbbVie that it requires three more months to review additional information about the results of liver function tests provided by the company as part of its NDA for elagolix in endometriosis-associated pain. The user fee review action target date has been extended to the third quarter.

The NDA is based on data from clinical trials conducted in about 1,700 women with moderate-to-severe endometriosis-associated pain. “Clinical trial data demonstrated elagolix was well-tolerated and significantly reduced the three types of endometriosis-associated pain — daily menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse,” AbbVie says.

Elagolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist that works by blocking endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland, according to the company. “Administration results in readily reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the ovarian sex hormones, estradiol and progesterone, while on therapy,” it says. The therapy is also currently being investigated in diseases that are mediated by ovarian sex hormones, such as uterine fibroids.

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