Vabysmo Label Expanded for Use Beyond Six Months

On April 9, 2026, the US Food and Drug Administration (FDA) approved Genentech’s, a member of the Roche Group, Vabysmo^® (faricimab‑svoa), an intravitreal injectable bispecific antibody, for the treatment of macular edema due to retinal vein occlusion (RVO) beyond six months in adults. Vabysmo is designed to inhibit both angiopoietin‑2 (Ang‑2) and vascular endothelial growth factor‑A (VEGF‑A) pathways, which are implicated in vascular destabilization and inflammation in retinal disease. The approval expands the existing RVO indication from use up to six months to treatment beyond six months, aligning the label with longer‑term clinical practice and reducing the need for treatment switching in patients who continue to benefit from therapy. Vabysmo is administered via intravitreal injection and is also approved for neovascular (wet) age‑related macular degeneration (AMD) and diabetic macular edema (DME). Updated prescribing information is available here.

First Xigduo XR Generics Launched

On April 6, 2026, Aurobindo Pharma announced approval of dapagliflozin and metformin hydrochloride extended-release tablets, 5mg/500mg, 5mg/1000mg, 10mg/500mg, and 10mg/1000mg, generic equivalents to AstraZeneca’s Xigduo^® XR tablets. They are expected to launch immediately. Indicated for type 2 diabetes, Aurobindo shares 180-day exclusivity with nine other entrants. Annual US sales for Xigduo XR were $514 million for the 12 months ending February 2026, according to IQVIA.

Filspari Approved for Focal Segmental Glomerulosclerosis

Travere Therapeutics received FDA approval on April 13, 2026, for Filspari® (sparsentan) tablets to reduce proteinuria in adults and pediatric patients eight years and older who have focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. FSGS is a rare, progressive glomerular disease that can cause chronic kidney disease (CKD) and end-stage kidney disease (ESKD). It has historically been managed with off-label corticosteroids and other immunosuppressants plus supportive renin angiotensin system (RAS) blockade such as angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs). Before initiating Filspari, clinicians should discontinue renin-antagonist aldosterone system (RAAS) inhibitors and endothelin receptor antagonists. There are an estimated 30,000 US patients who have FSGS without nephrotic syndrome who would be eligible for treatment. Filspari is the first FDA-approved therapy specifically for this population and works as a dual endothelin and angiotensin II receptor antagonist.  Approval was supported by the FDA’s evaluation of the phase III DUPLEX trial and supportive phase II DUET data, with the labeled indication emphasizing sustained proteinuria reduction despite not demonstrating statistical superiority over irbesartan on the primary endpoint of estimated glomerular filtration (eGFR) slope through week 108.  In DUPLEX, proteinuria decreased 46% from baseline to week 108 with Filspari vs. 30% in patients who took irbesartan.  The recommended dose for FSGS is weight-based. For patients weighing more than 50kg, the recommended starting dose is 400mg once daily for 14 days, then the dose can be increased to 800mg once daily as tolerated. For patients weighing 50kg or less, the recommended starting dose is 200mg once daily for 14 days, then the dose can be increased to 400mg once daily as tolerated. The Filspari Risk Evaluation and Mitigation Strategy (REMS) is a safety program that manages the risks for hepatotoxicity. Filspari is only available through the restricted program, which requires prescribers, patients, and certified pharmacies to enroll before it can be prescribed and dispensed.  Filspari is also indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.  Here is the prescribing information.

Wellcovorin Voluntary Withdrawal

GlaxoSmithKline requested the withdrawal of approval for Wellcovorin^® (leucovorin calcium) tablets. FDA approval withdrawal is effective April 10, 2026, after the company reported that the product is no longer marketed. Approved generic leucovorin products remain available, and the withdrawal applies only to the branded version. Therefore, generic leucovorin products will remain approved and listed for all previous indications, including the March 10, 2026, approval for the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). It is also indicated to reduce the toxicity of methotrexate in adult patients with impaired methotrexate elimination and to reduce the toxicity of folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. For full prescribing information, see here.

Rapid Rate Control Expands to Pediatrics

On April 15, 2026, the FDA approved AOP Health US’s Rapiblyk^® (landiolol), an intravenous (IV) ultra‑short‑acting, selective beta‑1 adrenergic receptor blocker, for the treatment of supraventricular tachycardia (SVT) in pediatric patients from birth to less than 18 years of age. This approval expands its prior adult indication and establishes the first FDA‑approved pharmacologic option for pediatric SVT. Approval was supported by the phase III, open‑label LANDI‑PED study, including 60 pediatric patients, which demonstrated a greater than 20% reduction in ventricular rate from baseline in appropriate pediatric patients, with 25% achieving conversion to normal sinus rhythm within 210 minutes of infusion initiation. It is administered as a continuous IV infusion, titrated based on heart rate, and hypotension is the most common adverse reaction, warranting close hemodynamic monitoring. Here is the updated prescribing information.