The FDA has recently approved several new medical products, including a digital therapeutic for generalized anxiety disorder (GAD), an updated COVID-19 vaccine, and a disposable insulin patch pump.
First Digital Therapeutic for Generalized Anxiety Disorder
The FDA granted clearance to DaylightRX, a digital therapeutic developed by Big Health, for the treatment of generalized anxiety disorder (GAD) as an adjunct to usual care in patients aged 22 years and older. This marks the first digital treatment approved for GAD in the United States. DaylightRX delivers cognitive behavioral therapy (CBT) through lessons that teach evidence-based techniques to reduce chronic worry and anxiety. These techniques include applied relaxation, stimulus control, cognitive restructuring, and exposure therapy. The therapy is available by prescription only and is based on Big Health’s existing digital care program, Daylight.
Updated Novavax COVID-19 Vaccine
The FDA has issued an emergency use authorization (EUA) for Novavax’s updated COVID-19 vaccine, NVX-CoV2705, for individuals aged 12 years and older. This protein-based vaccine is an updated 2024-2025 formula that includes a monovalent component corresponding to the Omicron variant JN.1 strain. Novavax stated the vaccine will be available in pharmacies and grocers across the United States once batches are released by the Center for Biologics Evaluation and Research. The EUA was supported by non-clinical data demonstrating cross-reactivity against JN.1 and related lineage viruses.
New Disposable Insulin Patch Pump for Diabetes
Embecta has received 510(k) clearance from the FDA for its proprietary disposable insulin delivery system, indicated for adults with type 1 diabetes (T1D) and type 2 diabetes (T2D). The design was informed by feedback from people with T2D. The wearable, fully disposable patch pump features a 300-unit reservoir and provides adjustable basal and bolus insulin for up to 3 days. This expanded reservoir is intended to better accommodate individuals with higher daily insulin needs, commonly seen in T2D, and those transitioning from multiple daily injections (MDI) to pump therapy.
BioVie's Bezisterim for Post-COVID-19 Condition
The FDA authorized BioVie’s investigational new drug application for bezisterim to treat neurological symptoms associated with post-COVID-19 condition. A phase 2, randomized, placebo-controlled, multicenter clinical trial will evaluate the safety and tolerability of bezisterim over 3 months of treatment in a cohort of 200 patients, as well as the drug’s potential ability to reduce the neurocognitive symptoms associated with long COVID. Bezisterim (NE3107) selectively inhibits the inflammatory extracellular signal-regulated kinase (ERK) pathway that reduces neuroinflammation by inhibiting inflammation-driven insulin resistance and major pathological inflammatory cascades. The drug is orally bioavailable and blood-brain-barrier permeable, is not immunosuppressive, and has a low risk of drug-drug interactions. Bezisterim modulates the activation of NFkB, which modulates inflammation.
