Drugs

Reviewers Raise Liver Safety in Cempra Drug

FDA medical reviewers are expressing concern about hepatotoxicity in Cempra’s solithromycin, which goes before the agency’s Antimicrobial Drugs Advisory Committee 11/4 seeking support for an indication to treat community acquired bacterial pneumonia (CABP). A briefing paper released in advance of the meeting says the rates of transaminase elevations were higher in solithromycin-treated patients than those treated with moxifloxacin and were related to solithromycin exposure. A high rate of infusion site-related reactions associated with solithromycin (31.3%) as compared to moxifloxacin (5.2%) is cited as another concern.

The paper says that rates of deaths and serious adverse events observed in the solithromycin and moxifloxacin arms of the trial were similar.

Solithromycin is described as a semi-synthetic antibacterial drug of the macrolide class/ketolide subclass developed by Cempra Pharmaceuticals for treating CABP caused by Streptococcus pneumoniae, Haemophilus influenza, Moraxella catarrhalis, methicillin-susceptible Staphulococcus aureus, Legionella pneumophila, and Mycoplasma pneumoniae.

The advisory committee is asked to discuss whether Cempra provided substantial evidence of the drug’s efficacy for the proposed indication, whether the risk of hepatotoxicity has been adequately characterized, and whether solithromycin’s risks outweigh the potential benefits in treating CABP.

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