Drugs

Reviewers Still See Heplisav Safety Concerns

FDA medical reviewers say that Dynavax’ hepatitis B vaccine Heplisav-B (hepatitis B vaccine recombinant and 1018 ISS adjuvant) is effective, but still has potential safety issues. The reviewers’ assessment is in a briefing document released in advance of a 7/28 Vaccines and Related Biological Products Advisory Committee meeting to consider the Heplisav BLA.

The document notes that there were more deaths and serious cardiac events in clinical trial patients who received Heplisav than in those who received GlaxoSmithKline’s Energix-B, a comparator product. However, the reviewers also said that overall numbers and rates of adverse events were low, and there were limitations in the evaluation of cardiac events that “limits the causal interpretation of these observations.”

The briefing says that FDA has twice rejected the vaccine because of unresolved safety concerns. Dynavax conducted additional clinical trials to try to respond to the agency’s concerns.

Dynavax is seeking an indication for active immunization against all subtypes of hepatitis B virus infection in adults age 18 and older. Advisory committee members will be asked to consider the vaccine’s safety and the company’s proposed pharmacovigilance plan, with a particular focus on the pre-licensure safety data to support licensure.

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