Drugs

Ipsen Gains Accelerated OK for Iqirvo

FDA has granted Ipsen accelerated approval for Iqirvo (elafibranor) 80 mg tablets for treating primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Approval was based on data showing the therapy’s use reduced alkaline phosphatase, the company says, noting that an improvement in survival or prevention of liver decompensation events have not been demonstrated. It notes that continued approval for the indication is contingent upon verification and description of clinical benefit in confirmatory trials.

“For a significant number of people living with PBC, available treatments do not control the condition and may exacerbate symptoms of PBC,” an Ipsen release says. “Left unmanaged, PBC can progress, leading to liver failure and in some cases, the need for a liver transplant.”

Iqirvo is described as a first-in-class oral, once-daily peroxisome proliferator-activated receptor agonist. The most common adverse reactions reported in more than 10% of study participants were weight gain, abdominal pain, diarrhea, nausea and vomiting. Some study participants treated with Iqirvo had “experienced myalgia, myopathy and rhabdomyolysis; fractures; adverse effects on fetal and newborn development; drug-induced liver injury; hypersensitivity reactions; or biliary obstruction,” Ipsen 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