Drugs

FDA OKs Merck’s Zepatier for Hep C

FDA has approved a Merck NDA for Zepatier (elbasvir and grazoprevir) with or without ribavirin for treating chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients. Approval is based on clinical trial data from 1,373 participants with chronic HCV genotype 1 or 4 infections with and without cirrhosis. Participants received Zepatier with or without ribavirin once daily for 12 or 16 weeks, according to an agency release. The overall sustained virologic response (SVR) rates ranged from 94-97% in genotype 1-infected subjects and from 97-100% in genotype 4-infected subjects across trials for the approved treatment regimens, it says.

The most common side effects of Zepatier without ribavirin were fatigue, headache and nausea; and with ribavirin they were anemia and headache. The therapy’s labeling carries a warning alerting patients and health care providers that elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1% of clinical trial participants, generally at or after treatment week eight, FDA says. “Liver-related blood tests should be performed prior to starting therapy and at certain times during treatment,” it adds. Additionally, it says Zepatier should not be given to patients with moderate or severe liver impairment.

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