Drugs

FDA Warns of Serious Liver Risks Linked to Tavneos

FDA has issued a safety alert warning that patients taking Amgen’s Tavneos (avacopan) for a rare autoimmune condition may face a risk of severe liver injury, including cases that have resulted in death. The agency says it has identified postmarketing reports of drug-induced liver injury (DILI) in patients treated with Tavneos, including instances of vanishing bile duct syndrome (VBDS), a rare but potentially irreversible disorder marked by the progressive loss of bile ducts. The condition can disrupt bile flow and lead to permanent liver damage. Symptoms may include jaundice, itching and fatigue.

While liver toxicity was already documented in pre-approval clinical trials and is reflected in the drug’s labeling, the FDA emphasized that the emergence of VBDS and fatal DILI cases represents a new and more serious safety concern, according to a safety alert.

Tavneos is approved for use in combination with glucocorticoids and other therapies to treat adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, including granulomatosis with polyangiitis and microscopic polyangiitis — rare diseases characterized by inflammation of small- to medium-sized blood vessels.

Earlier this year, Amgen pushed back against an FDA request asking it to voluntarily withdraw the drug from the U.S. market due to concerns related to clinical trial adjudication and liver safety. In an Amgen notice to healthcare providers, the company says it has no plans to withdraw the 2021-approved drug and is working with the agency to determine a path forward.

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