Drugs

FDA Accepts Jardiance sNDA to Add CV Outcomes Data

FDA has accepted for review a Boehringer Ingelheim and Eli Lilly supplemental NDA for Jardiance (empagliflozin) that seeks to add to the approved label cardiovascular (CV) risk reduction data from the landmark EMPA-REG OUTCOME trial. “Cardiovascular complications can have a significant impact on the health and life expectancy of people with Type 2 diabetes,” the companies say, adding that about 50% of deaths in people with Type 2 diabetes worldwide are caused by cardiovascular disease. Jardiance was approved by FDA in 2014 as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. For years, the agency has required CV outcomes trials for new diabetes drugs as a post-marketing requirement.

In its trial, Jardiance was shown to significantly reduce the risk of CV death, non-fatal heart attack or non-fatal stroke by 14% versus placebo, the companies say. “Risk of CV death was reduced by 38%, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke,” they say. “Treatment with Jardiance also resulted in a 32% reduction in all-cause mortality and a 35% reduction in hospitalization for heart failure. The overall safety profile of Jardiance was consistent with that of previous trials.”

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