FDA Roundup: April 30, 2024

FDA News Release

• For Immediate Release: April 30, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today the FDA, in coordination with the U.S. Department of Justice (DOJ), announced that the U.S. Marshals Service seized unauthorized e-cigarette products valued at more than $700,000. The e-cigarettes were located in a warehouse in Alhambra, CA, and are believed to be owned by several California-based distributors. The seized products were mostly flavored, disposable e-cigarette products, including youth-appealing brands such as Puff Bar/Puff, Elf Bar/EB Design, Esco Bar, Kuz, Smok, and Pixi. 
• On Monday, the FDA authorized marketing of Sensonics, Inc.’s Eversense AP CGM System that includes a fully implantable sensor with an anti-inflammatory drug (dexamethasone acetate) that is slowly released onto the skin to reduce inflammation at the sensor insertion site. This authorization creates a new pathway for integrated continuous glucose monitoring (iCGM) systems that are combination products to come to market. The Eversense AP CGM System is intended to replace fingerstick blood glucose measurements for diabetes treatment decisions, provide real-time glucose reading, glucose trend information, and alerts for episodes of low or high blood glucose levels (hypo and hyperglycemia). Adverse events reported in the study included local infection, skin irritation and pain or discomfort. This prescription-only system is intended for people with diabetes 18 years of age and older and can be used alone or in conjunction with digitally connected medical devices, including automated insulin dosing systems. 
• On Monday, the FDA granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc. [now a part of Pfizer Inc.]) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received accelerated approval for this indication. The most common adverse reactions (≥25%), including laboratory abnormalities, were decreased hemoglobin, peripheral neuropathy, conjunctival adverse reactions, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, fatigue, decreased sodium, epistaxis, and constipation. Full prescribing information for Tivdak will be posted here. 
• On Monday, the FDA announced it will host a listening session on June 13, 2024 as part of its broader work to optimize the use of, and processes for, advisory committees. This virtual public meeting will focus on the composition of advisory committees, ways to improve the experience for members serving on committees and ways to ensure public awareness and understanding of the role of the FDA advisory committees. For more information and to register, please visit Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees - 06/13/2024.
• On Monday, the FDA published the Advisory Committees Give FDA Critical Advice and the Public a Voice Consumer Update to help people better understand how the FDA relies on advisory committees to help make sound decisions based on the best science available. Advisory committees give FDA experts outside, independent, and professional advice on various complex scientific, technical, and policy issues.
• On Friday, the FDA announced it had made a risk-based decision based on its review of safety and quality data and information and does not expect the developer of PrecisePRP Canine (canine leucoreduced allogeneic pooled freeze-dried platelet-rich plasma) to submit an application for approval prior to marketing. PrecisePRP Canine provides a species-specific source of concentrated platelets in plasma for injection directly into a dog’s joint (intra-articular injection) and is the first animal cell, tissue, and cell- and tissue-based product (ACTP) intended for intra-articular use to undergo FDA review and receive this determination.
• On Friday, the FDA approved Abbot Medical’s Espirt BTK Everolimus Eluting Resorbable Scaffold System, a first-of-a-kind Breakthrough device to treat patients with chronic limb-threatening ischemia (CLTI). A severe form of Peripheral Artery Disease, CLTI is a result of a collection of fatty substances and calcification that form plaque along the lining of the arteries and is associated with pain, unhealing wounds and amputation of the lower leg and foot and increased mortality. The Esprit BTK system is mounted on a catheter and delivered to the lower leg to open narrowed arteries with the intention of restoring blood flow while delivering an anti-proliferative drug to keep the vessel from re-narrowing. The device is contraindicated for use in patients with allergy or hypersensitivity to device materials or with certain anticoagulation or antiplatelet regimens.
• On Friday, the FDA posted a new video in the “FDA In Your Day” series. In this video, Principal Deputy Commissioner Dr. Namandjé Bumpus discusses Drug Takeback Day, National Minority Health Month, and counterfeit Botox.