Drugs

FDA Approves Epclusa to Treat Hepatitis C

FDA says it has approved Gilead’s Epclusa to treat adults who have chronic hepatitis C virus (HCV) either with or without cirrhosis. An agency statement says that it is the first drug regimen to treat all six major HCV genotypes. For patients with moderate to severe cirrhosis, the statement says, Epclusa is approved for use in combination with ribavirin.

Epclusa is described as a fixed-dose combination tablet containing sofosbuvir, approved in 2013, and velpatasvir, a new drug. Its safety and efficacy were evaluated in three Phase 3 trials of 1,558 subjects without cirrhosis or with mild cirrhosis. Results showed that 95% to 99% of patients who received Epclusa had no virus detected in the blood 12 weeks after finishing treatment. Its safety and efficacy also were evaluated in a trial of 267 subjects with moderate to severe cirrhosis. Some 94% of patients who received Epclusa and ribavirin had no virus detected in the blood 12 weeks after finishing treatment.

FDA says the drug’s most common side effects include headache and fatigue. The labeling contains a Warning that symptomatic bradycardia and cases requiring pacemaker intervention have been reported when the heart rhythm drug amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral. There also is a Warning not to use Epclusa with certain drugs that may reduce the Epclusa level in the blood, which could lead to reduced efficacy.

The drug was reviewed under the agency’s priority review program.

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