Drugs

Merck’s RSV Therapy Approved by FDA

FDA has approved a Merck BLA for Enflonsia (clesrovimab-cfor) for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. The long-acting monoclonal antibody is designed to provide direct, rapid and durable protection through five months, a typical RSV season, with the same 105 mg dose regardless of weight, the company says.

Approval was based on data from the pivotal Phase 2b/3 CLEVER trial (MK-1654-004) evaluating a single dose of Enflonsia administered to preterm and full-term infants (birth to one year of age). The trial met its primary and key secondary endpoints, as follows:

The therapy demonstrated a 61% reduction in incidence of RSV-associated medically attended lower respiratory infections compared to placebo.
It demonstrated an 84% reduction in RSV-associated hospitalizations and showed increasing efficacy with increasing disease severity.

Regarding safety, Merck says Enflonsia should not be administered to infants with a history of serious hypersensitivity reactions to any of the therapy’s components. “Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human immunoglobulin G1 (IgG1) monoclonal antibodies,” it says. The most common adverse reactions reported were injection-site erythema (3.8%), injection-site swelling (2.7%) and rash (2.3%).

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