Saphnelo SC Autoinjector Approved
On April 24, 2026, the US Food and Drug Administration (FDA) approved AstraZeneca’s Saphnelo® (anifrolumab‑fnia) for subcutaneous (SC) self‑administration as a once‑weekly autoinjector for the treatment of adult patients who have moderate to severe systemic lupus erythematosus (SLE). The Saphnelo Pen allows patients to self‑inject at home, expanding administration options beyond the previously approved intravenous (IV) infusion given in clinical settings. Approval was based on a statistically significant and clinically meaningful reduction in disease activity versus placebo at week 52, with a safety profile consistent with IV Saphnelo, including risk of serious infections, hypersensitivity reactions, avoidance of live vaccines during treatment and increased risk of malignancy when used with immunosuppressants. Saphnelo is a type I interferon receptor antagonist, with a recommended dose is 120mg administered SC once weekly. Launch and cost are not yet known. Here is the updated prescribing information.
Breztri Gets New Indication for Asthma
The FDA approved AstraZeneca’s Breztri Aerosphere® (budesonide/glycopyrrolate/formoterol fumarate) inhalation aerosol for the maintenance treatment of asthma in adult and pediatric patients aged 12 years and older. Breztri combines an inhaled corticosteroid (ICS), a long‑acting beta‑agonist (LABA) and a long‑acting muscarinic antagonist (LAMA) in one device. Originally approved in 2020 to treat adults with chronic obstructive pulmonary disease (COPD), this indication expansion marks the first fixed‑dose triple‑combination, single‑inhaler therapy available for asthma. Approval was based on statistically significant and clinically meaningful improvements in lung function versus dual ICS/LABA therapy, including rapid onset, with improvement observed within five minutes after the first dose. For asthma maintenance, patients should take two oral inhalations of Breztri Aerosphere (160mcg/18mcg/4.8mcg) twice daily. This is a maintenance therapy and is not indicated for acute bronchospasm or as a rescue inhaler. Full prescribing information is available here.
New Indication for Auvelity for Agitation in Alzheimer’s Disease
On April 30, 2026, the FDA approved Axsome Therapeutics’ Auvelity® (dextromethorphan hydrobromide and bupropion hydrochloride) extended‑release oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease in adults. Auvelity was previously approved for major depressive disorder in 2022 and acts through N-methyl D-aspartate (NMDA) receptor antagonism and sigma‑1 receptor modulation, offering a pharmacologic approach distinct from antipsychotics. This represents the first non‑antipsychotic therapy approved for this indication. Approval was supported by two randomized studies, including a five‑week placebo‑controlled trial demonstrating statistically significant improvement in Cohen‑Mansfield Agitation Inventory (CMAI) scores, and a randomized‑withdrawal study showing significantly longer time to relapse of agitation symptoms versus placebo. The recommended dosing for agitation is initiated at 30mg/105mg once daily in the morning, with titration to twice‑daily dosing on day eight and up to 45mg/105mg twice daily by day 15, as tolerated. Updated prescribing information may be found here.
FDA Approves Caplyta Label Update for Schizophrenia Relapse Prevention
Johnson and Johnson announced a label update was approved for Caplyta® (lumateperone) to incorporate long‑term maintenance data supporting relapse prevention in adults who have schizophrenia. The FDA decision was issued on April 27, 2026, following review of phase III study results showing that adults stabilized on Caplyta 42mg once daily had a significantly longer time to relapse compared with placebo, with a 63% reduction in relapse risk and 84% remaining relapse-free at six months. Caplyta is an oral atypical antipsychotic developed by Intra‑Cellular Therapies whose effects are thought to be mediated through serotonin 5‑HT₂A receptor antagonism and dopamine D₂ receptor partial agonism. Schizophrenia is a chronic, relapsing psychiatric disorder associated with substantial functional impairment and high health care utilization, making relapse prevention a key objective in long‑term management. The recommended dosage of Caplyta for schizophrenia is 42mg orally once daily, with or without food, and no titration is required. Caplyta has a boxed warning for increased mortality in elderly patients who have dementia‑related psychosis. The updated prescribing information is available here.
Novo Nordisk Retires Rybelsus Brand as Oral Ozempic Pill Launches
Novo Nordisk announced it has retired the Rybelsus® brand in the US, consolidating its oral semaglutide portfolio under the Ozempic® (semaglutide) pill brand. The oral formulation, which was approved earlier this year under the Ozempic proprietary name, contains the same active ingredient as Rybelsus and represents a rebranding and updated formulation rather than a new molecular entity. The intent is to align oral and injectable semaglutide under a single brand name to simplify prescribing and improve patient recognition. It will be available at doses of 1.5mg, 4mg and 9mg for use in adults with type 2 diabetes to improve glycemic control as an adjunct to diet and exercise and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes at high cardiovascular risk. The company plans to make the Ozempic pill available nationally beginning May 4. Here is the prescribing information.