Drugs

FDA Approves Gileads Vosevi for Hepatitis C

FDA has approved Gilead’s Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to treat adults with chronic hepatitis C virus genotypes 1-6 without cirrhosis or with mild cirrhosis. An agency news release says Vosevi is a fixed-dose, combination tablet containing two previously approved drugs (sofosbuvir and velpatasvir) and a new drug (voxilaprevir). It is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other hepatitis C drugs that inhibit a protein called NS5A, FDA says.

Vosevi’s safety and efficacy were evaluated in two Phase 3 trials involving about 750 adults without cirrhosis or with mild cirrhosis.

The agency says the results of both trials demonstrated that 96-97% of patients who received Vosevi had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infections had been cured. The most common adverse reactions in patients taking the drug were headache, fatigue, diarrhea, and nausea.

FDA says that treatment recommendations for Vosevi differ depending on viral genotype and prior treatment history.

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