Drugs

FDA Accepts Amgen sBLA for Prolia

FDA has accepted an Amgen supplemental BLA for Prolia (denosumab) for treating patients with glucocorticoid-induced osteoporosis. The agency has set a user fee review action target date of 5/28/2018.

The submission is based on a Phase 3 study evaluating Prolia compared with risedronate in patients receiving glucocorticoid treatment. The study included two patient groups: those receiving continuing glucocorticoid therapy and those newly initiating glucocorticoid therapy. It met the primary endpoint (percent change from baseline in lumbar spine bone mineral density (BMD) at 12 months, assessing non-inferiority) and all secondary endpoints assessed at 12 months (the percent changes from baseline in lumbar spine and total hip BMD, assessing superiority), according to the company. Data showed that, in patients receiving continuing glucocorticoid therapy, Prolia treatment led to greater gains in BMD, compared with risedronate, it says.

Prolia is currently approved for treating postmenopausal women with osteoporosis at high risk for fracture. It is also approved for increasing bone mass in men with osteoporosis at high risk for fracture. Additionally, it is indicated to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

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