The amyloid beta-directed monoclonal antibody lecanemab-irmb (Leqembi – Eisai/Biogen) has now been approved by the FDA for once-monthly use for treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia. It was previously approved only for administration once every 2 weeks. Now, lecanemab can be given every 4 weeks after an 18-month initiation phase of biweekly administration.

Eylea HD (Regeneron), which contains 8 mg of the vascular endothelial growth factor (VEGF) inhibitor aflibercept, has now been approved by the FDA for intravitreal treatment of macular edema following retinal vein occlusion (RVO). A 2-mg dose of aflibercept (Eylea) was approved previously for this indication. Eylea and Eylea HD are also approved for treatment of neovascular (wet) age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.

The FDA has required updates to the boxed warnings in the labeling of the Janus kinase (JAK) inhibitors tofacitinib (Xeljanz, Xeljanz XR), baricitinib (Olumiant), and upadacitinib (Rinvoq) describing increased risks of major adverse cardiovascular events, malignancy, thrombosis, and death with their use. The new warnings were prompted by the results of a postmarketing safety trial with tofacitinib and were added to the labels of baricitinib and upadacitinib based on the presumption of a class effect. The tofacitinib package insert had contained a boxed warning about an increased...

The FDA has expanded its Emergency Use Authorizations (EUAs) for the COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of the bivalent formulations of these products (containing mRNA from the original and BA.4/5 Omicron strains of SARS-CoV-2) in children as young as 6 months. The bivalent Pfizer vaccine is authorized for use as the final dose of a 3-dose primary series in children 6 months to 4 years old. The bivalent Moderna vaccine is authorized for use as a booster dose in children 6 months to 5 years old who completed a primary...

The interleukin-6 (IL-6) receptor antagonist tocilizumab (Actemra – Genentech) has been approved by the FDA for IV treatment of COVID-19 in hospitalized adults who are receiving a systemic corticosteroid and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Tocilizumab was previously available for this indication under an Emergency Use Authorization (EUA); it remains available under an EUA for treatment of children 2-17 years old who are hospitalized with COVID-19 and require oxygen support.

The package inserts of the GLP-1 receptor agonists dulaglutide (Trulicity), exenatide (Byetta, Bydureon BCise), liraglutide (Saxenda, Victoza), and semaglutide (Ozempic, Rybelsus, Wegovy) and the dual glucosedependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist tirzepatide (Mounjaro, Zepbound) have been updated to include rare postmarketing reports of pulmonary aspiration associated with their use in patients undergoing elective surgery or other procedures requiring general anesthesia or deep sedation who had residual gastric contents despite preoperative...

Omlyclo (omalizumab-igec; Celltrion), a biosimilar product interchangeable with the recombinant anti-IgE monoclonal antibody Xolair, has been approved by the FDA for same indications as Xolair (see Table 1). Omlyclo is the first Xolair biosimilar to be approved in the US.

In our article in issue 1687 on the updated 2023-2024 COVID-19 vaccines from Pfizer and Moderna (Med Lett Drugs Ther 2023; 65:161), the doses and formulations of the Pfizer vaccine were incorrect. A revised table has been posted in the online version of the article.

Penpulimab-kcqx (Anniko – Akeso Biopharma), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin or carboplatin plus gemcitabine for first-line treatment of recurrent or metastatic nonkeratinizing nasopharyngeal carcinoma and for use as monotherapy for metastatic disease in adults with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Penpulimab is the second immune checkpoint inhibitor to be approved in the US for treatment of nasopharyngeal carcinoma;...

Elecsys Phospho-Tau (181P) Plasma (Roche), a blood-based diagnostic test, has been cleared by the FDA to aid in the initial assessment of amyloid plaque pathology associated with Alzheimer's disease (AD) in patients ≥55 years old with signs of cognitive decline. It is the second blood test for AD biomarkers to be cleared by the FDA; the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test was cleared in 2025 (see Table 1).