February 2026

PDR Drug Update 

On-Demand Therapy for PSVT

Millions of individuals experience episodes of rapid heart rhythm known as paroxysmal supraventricular tachycardia (PSVT). Instances of PSVT occur suddenly, with patients often experiencing racing heartbeats of 200 beats per minute or more. The uncertain nature of when an episode may occur, along with the accompanying symptoms of the palpitations, equates to a stressful and even debilitating state for those with the condition. A noteworthy new therapy has obtained regulatory approval, bringing the first self-administered treatment option for PSVT to patients.

PSVT is a subset of supraventricular tachycardias that originate in the atria or atrioventricular (AV) node and start and stop abruptly, and may recur over several minutes or days. PSVT can occur in both adult and pediatric patients. In addition to an accelerated heart rate, patients may experience dyspnea, severe palpitations, chest discomfort, weakness, nausea, dizziness, or syncope. In addition, anxiety and concerns about the unpredictable onset of symptoms may be factors that patients with PSVT contend with that interfere with and impede daily activities. While PSVT is usually not life-threatening, frequent or prolonged episodes can impair quality of life and, in rare cases, contribute to cardiomyopathy if left untreated.

Diagnosis of PSVT is typically confirmed by a 12-lead electrocardiogram captured during an episode of arrhythmia and after cardioversion. Initial acute management in stable patients typically includes vagal maneuvers to enhance vagal tone and interrupt the reentrant circuit. Vagal maneuvers may include having the patient cough forcefully or holding the nostrils closed while attempting to expel air through them. Another method used is carotid sinus massage, with gentle pressure applied to the neck over where the carotid artery splits into two branches.

When vagal maneuvers fail or are inappropriate, anti-arrhythmic medications are used for treatment. Adenosine is frequently used in clinical settings for rapid termination because of its short half-life and its effectiveness in transiently blocking AV nodal conduction. Intravenous non-dihydropyridine calcium channel blockers such as verapamil or diltiazem may also be considered subsequently. In recurrent or refractory cases, catheter ablation offers a definitive treatment, often with remarkably high success rates.

The newest treatment option to become available is the recently FDA-approved nasal spray Cardamyst (etripamil). It is indicated for the conversion of acute symptomatic PSVT episodes to normal sinus rhythm in adults outside of healthcare settings. This approval represents the first self-administered pharmacologic option specifically indicated for PSVT in decades and offers patients autonomy in managing acute episodes. Etripamil is a short-acting, calcium channel inhibitor delivered intranasally. By rapidly inhibiting calcium influx in the AV nodal cells, it slows AV nodal conduction and disrupts the reentrant circuit sustaining PSVT, aiding return to sinus rhythm. The intranasal route enables quick absorption and rapid onset of action, making it suitable for on-demand use. In clinical trials, patients taking etripamil were twice as likely to convert symptomatic PSVT to sinus rhythm and did so three times faster than patients taking a placebo.

The advent of intranasal etripamil marks a paradigm shift in PSVT management by empowering patients with a rapid, self-administered treatment option. Positive outcomes may include reduced reliance on emergency care and improved patient quality of life, enabling swift termination of episodes outside clinical environments. Ongoing post-marketing surveillance and further studies will continue to refine its role in patient care. Stay informed about emergent drug information, including medications for arrhythmia management, by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Approvals

Aqvesme

The FDA has approved Aqvesme (mitapivat), an oral pyruvate kinase activator, for the treatment of anemia in adults with alpha- or beta-thalassemia. Learn more about Aqvesme

Boncresa

The FDA has approved Boncresa (denosumab-mobz), a biosimilar referencing Prolia, for treatment: of postmenopausal women with osteoporosis at high risk for fracture; to increase bone mass in men with osteoporosis at high risk for fracture; of glucocorticoid-induced osteoporosis in men and women at high risk for fracture; to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Learn more about Boncresa

Fesilty

The FDA has approved Fesilty (fibrinogen, human-chmt) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia. Learn more about Fesilty

Myqorzo

The FDA has approved Myqorzo (aficamten) tablets for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms. Learn more about Myqorzo

Nereus

The FDA has approved Nereus (tradipitant) for the prevention of motion-induced vomiting. Learn more about Nereus

Nufymco

The FDA has approved Nufymco (ranibizumab-leyk), a biosimilar referencing Lucentis, for the treatment of patients with age-related neovascular (wet) macular degeneration and other serious eye diseases, including diabetic macular edema, diabetic retinopathy, macular edema due to retinal vein occlusion, and myopic choroidal neovascularization. Learn more about Nufymco

Oziltus

The FDA has approved Oziltus (denosumab-mobz), a biosimilar referencing Xgeva, for: prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors; treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Learn more about Oziltus

Yartemlea

The FDA has approved Yartemlea (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Learn more about Yartemlea

Zycubo

The FDA has approved Zycubo (copper histidinate) as the first treatment for Menkes disease in pediatric patients. Learn more about Zycubo

FDA New Indications

Accrufer

The FDA has approved an extension of the indication for Accrufer (ferric maltol) to include adolescents. Accrufer is now indicated for the treatment of iron deficiency in adult and pediatric patients aged 10 years and older. Learn more about Accrufer

Cablivi

The FDA has approved Cablivi (caplacizumab-yhdp) for injection to treat pediatric patients aged 12 years and older with acquired thrombotic thrombocytopenic purpura in combination with plasma exchange and immunosuppressive therapy. Cablivi was previously indicated only for adults with this condition. Learn more about Cablivi

Furoscix

The FDA has approved an expanded indication for Furoscix (furosemide) on-body infusor to include pediatric patients weighing 43kg or more. Furoscix was previously approved for the treatment of edema associated with chronic heart failure and chronic kidney disease in adults. Learn more about Furoscix

Jascayd

The FDA has approved Jascayd (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis in adults. Learn more about Jascayd

FDA New Formulations

Lunsumio Velo

The FDA has granted accelerated approval of Lunsumio Velo (mosunetuzumab), a subcutaneous formulation, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Full approval for this regimen may be contingent on verification and confirmation of benefit in a confirmatory trial. Learn more about Lunsumio Velo

Wegovy

The FDA has approved oral Wegovy (semaglutide) 25mg, a once-daily pill to reduce excess body weight and maintain weight reduction long term and to reduce the risk of major adverse cardiovascular events. Learn more about Wegovy

FDA Recalls

Anthony Trinh, 123Herbals Silintan

Anthony Trinh, 123herbals LLC is voluntarily recalling all lots of Silintan capsules to the consumer level. FDA analysis has found the product to be tainted with meloxicam. Learn more about the Silintan recall

Gold Star Distribution Products

Gold Star Distribution, Inc. is recalling all FDA-regulated products listed in the associated press release due to the presence of rodent and avian contamination. Persons handling or consuming the products could become seriously ill due to adulteration from pests, including rodents, birds, and insects. Learn more about the Gold Star products recall

Modern Warrior Supplements

Modern Warrior is voluntarily recalling all lots of Modern Warrior Ready, a dietary supplement sold directly to consumers, after regulatory testing identified undeclared ingredients, including tianeptine, 1,4-DMAA, and aniracetam. Learn more about the Modern Warrior Ready recall

FDA Drug Safety Communications

Removal of Warning from GLP-1 RAs

The FDA is requesting that drug application holders remove information regarding the risk of suicidal ideation and behavior from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that currently include such language. The affected products are Saxenda (liraglutide), Wegovy (semaglutide), and Zepbound (tirzepatide). Learn more about the GLP-1 RA drug safety communication

FDA REMS

Boncresa

The FDA has approved a REMS for Boncresa (denosumab-mobz). The goal of the Boncresa REMS is to mitigate the risk of severe hypocalcemia in patients with advanced chronic kidney disease, including dialysis-dependent patients. Learn more about Boncresa

Myqorzo

The FDA has approved a REMS for Myqorzo (aficamten). The goal of the Myqorzo REMS is to mitigate the risk of heart failure due to systolic dysfunction. Learn more about Myqorzo

Labeling Updates - No updates this month