Biologics

Panel Backs GSK Vaccine for RSV in Older Adults

FDA’s Vaccines and Related Biological Products Advisory Committee 3/1 voted 10 to 2 and 12 to 0, respectively, that safety data and effectiveness data were adequate to support approval of GSK’s vaccine Arexvy (RSVPreF3-AS01E) for preventing lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 60 years and older.

In a briefing document released in advance of the meeting, FDA reviewers said vaccine efficacy against first occurrence of RSV-associated lower respiratory tract disease was 82.6%. On the safety side, the document said there was at least one potential immune mediated disease (pIMD) reported in 0.4% and 0.3% of vaccine and placebo recipients in the four Phase 3 studies. “Among vaccine recipients, one pIMD (Guillain-Barre syndrome that occurred nine days after RSVPreF3-AS01 E vaccination) was considered by the study investigator and FDA to be related to vaccination,” it said. “Six pIMDs (Bell’s palsy [n=2], pancytopenia, Graves’ disease [hyperthyroidism], gout, and psoriasis) were considered as possibly related to RSVPreF3-AS01E vaccination by the study investigators and by FDA.”

Many panel members urged FDA to thoroughly review expected data from GSK in April before approving the vaccine just to be sure there are no surprises. The user fee review action data is 5/3.

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

Read more

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