ON101 (Fespixon, Oneness Biotech), a first-in-class, macrophage-regulating, wound-healing cream for diabetic foot ulcers has shown benefit over absorbent dressings in a phase 3 trial, with another trial ongoing. The published trial showed that foot ulcers treated with ON101 cream were almost three times more likely to be completely healed at 16 weeks than those treated with standard care with an absorbent dressing (Aquacel Hydrofiber, ConvaTec) (odds ratio, 2.84; P < .001).
Source: Medscape
Subcutaneous vedolizumab appears to be an effective and safe maintenance therapy for some patients with moderate to severe active Crohn’s disease, according to results of a phase-3 trial. Vedolizumab, the first gut-selective biologic for the treatment of inflammatory bowel disease, now offers IV and SC routes of administration for maintenance therapy.
Source: Journal of Crohn’s and Colitis
The US FDA has approved the Vivistim System (MicroTransponder), a first-of-its kind vagus nerve stimulation (VNS) system intended to treat moderate-to-severe upper extremity motor deficits associated with chronic ischemic stroke. The Vivistim® System stimulates the vagus nerve while the patient is undergoing a rehabilitative movement, which tells the brain to “pay attention” to that movement. This simultaneous pairing of a specific movement with vagus nerve stimulation (VNS) strengthens motor circuits associated with the physical movement. Consistently pairing VNS with specific neural circuits helps rebuild those circuits and the brain relearns the commands to enable the muscles to perform specific tasks and can strengthen those muscles as well. This simultaneous pairing of muscle movement with VNS strengthens the neural circuits in the brain. Over time, a patient may regain upper limb function.
Source: MicroTransponder
The addition of dapagliflozin to standard therapy reduced the relative risk for the primary composite endpoint of any serious ventricular arrhythmia, resuscitated cardiac arrest, or sudden death by 21%. Dapagliflozin and other SGLT2 inhibitors have favorable effects on adverse cardiac remodeling, which contributes to sudden death and ventricular arrhythmia. They’ve also been shown to reduce cardiac chamber size, left ventricular hypertrophy, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels over time, consistent with a reduction in in myocardial wall stress.
Source: Medscape
The approval covers all three brivaracetam (BRIVIACT) formulations (tablets, oral solution, and IV) and marks the first time the IV formulation will be available for children.
Dosage:
Adverse reaction: Most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are somnolence/sedation, dizziness, fatigue, and nausea/vomiting.
Source: UCB
The US Food and Drug Administration has approved Medtronic’s Evolut FX system for transcatheter aortic valve replacement (TAVR) in patients with symptomatic severe aortic stenosis at all risk levels. The Evolut FX system features a self-expanding, supra-annular valve and is designed to enhance ease-of-use and provide greater precision and control throughout the procedure. The fourth-generation device is equipped with gold markers built into the frame to provide direct visualization of depth and valve leaflet location during implant.
Source: Medscape
The US FDA has approved an expanded peripheral artery disease (PAD) indication for the direct oral anticoagulant rivaroxaban to include patients who have undergone recent lower-extremity revascularization due to symptomatic PAD. The approved regimen in this patient population is rivaroxaban 2.5 mg twice daily with aspirin 100 mg once daily. Rivaroxaban with aspirin is the first and only treatment indicated for both coronary artery disease (CAD) and PAD.
Source: Medscape
Bimekizumab (Bimzelx), a humanized IgG1 monoclonal antibody, is the first approved treatment for moderate to severe plaque psoriasis that selectively inhibits interleukin (IL)–17A and IL-17F.
Dose: 320 mg, given in two subcutaneous injections every 4 weeks to week 16, then every 8 weeks.
Adverse effects: Upper respiratory tract infections (a majority of which were nasopharyngitis), reported by 14.5% of patients, followed by oral candidiasis, reported by 7.3%.
Bimekizumab is contraindicated for individuals with clinically important active infections such as tuberculosis, and for individuals with any hypersensitivity to the active substance.
Source: MDedge
The US Food and Drug Administration (FDA) has expanded indication for the noninvasive BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMSTM) System to include treatment of comorbid anxiety symptoms in adult patients with depression, the company has announced. The neurostimulation system has previously received FDA approval for treatment-resistant major depression, obsessive-compulsive disorder, and smoking addiction.
Source: Medscape
The persistent breathing issues that plague some COVID-19 survivors, known as ‘long COVID,’ may be due to microscopic processes that continue to damage lungs even after the acute infection is over, new findings suggest. Researchers studied blood and bronchoalveolar fluid samples from 38 patients who still had breathing problems at least three months after they were discharged from hospital.
Source: Medrxiv.org
