Drugs

Chronic Hepatitis Delta Virus Infection Treatment Approved

FDA has granted Gilead Sciences an accelerated approval for Hepcludex (bulevirtide-gmod) for treating chronic hepatitis delta virus (HDV) infection, marking the first FDA-approved therapy for the rare but potentially life-threatening liver disease. The approval covers treatment in adults with chronic hepatitis delta virus infection who do not have cirrhosis or who have compensated cirrhosis, the agency says.

HDV is considered the most severe form of chronic viral hepatitis and can rapidly lead to liver fibrosis, liver failure, liver cancer and death. The virus occurs only in people already infected with hepatitis B virus.

FDA says the approval action was based on data from the Phase 3 MYR301 trial, a randomized, open-label study evaluating once-daily Hepcludex treatment. The study’s primary endpoint measured a combined virologic and biochemical response at 48 weeks, defined as either undetectable HDV RNA or at least a 2 log decline in viral levels along with normalization of alanine aminotransferase levels.

At week 48, 48% of patients receiving Hepcludex achieved the combined response compared with 2% in the delayed-treatment control group, according to FDA. The proportion of patients achieving undetectable HDV RNA increased over time, reaching 20% at week 48, 36% at week 96 and 50% at week 144.

The drug carries a Boxed Warning that discontinuation may trigger severe acute exacerbations of both HDV and HBV infection. Common side effects included injection site reactions, headache, abdominal pain, fatigue and itching, while serious hypersensitivity reactions, including anaphylaxis, were also noted in the prescribing information, 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