Drugs

FDA Approves Intercept Pharma’s Ocaliva for Liver Disorder

FDA has granted Intercept Pharmaceuticals accelerated approval for Ocaliva (obeticholic acid) for treating primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA. The condition causes the small bile ducts in the liver to become inflamed, damaged and ultimately destroyed, which causes bile to remain in the liver and leads to cirrhosis.

Ocaliva was shown to bind to the farnesoid X receptor (FXR), found in the nucleus of cells in the liver and intestine, according to an FDA release. “FXR is a key regulator of bile acid metabolic pathways,” it says. “Ocaliva increases bile flow from the liver and suppresses bile acid production in the liver, thus reducing the exposure of the liver to toxic levels of bile acids.”

Approval was based on a reduction in the level of the biomarker alkaline phosphatase (ALP), a surrogate endpoint which the agency says could be relied upon to be reasonably likely to predict clinical benefit, including an improvement in transplant free-survival. Clinical data from 216 participants showed that after twelve months, the proportion of participants achieving reductions in ALP levels was higher among Ocaliva-treated participants compared to those on placebo, it 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