The sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin has been available for years alone (Jardiance – Boehringer Ingelheim) and in combination with metformin (Synjardy) to improve glycemic control in adults with type 2 diabetes. Both products have now been approved for use in children ≥10 years old. Empagliflozin is the second oral drug to become available in the US for treatment of type 2 diabetes in children; metformin has been available since 2000 for this indication. The injectable glucagon-like peptide-1 (GLP-1) receptor agonists liraglutide (Victoza) and...

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.

The FDA has approved a higher-dose injectable formulation of the opioid antagonist naloxone (Zimhi – Adamis) for emergency treatment of opioid overdose. A single IM or SC injection of the new formulation delivers 5 mg of naloxone; injectable formulations that deliver 0.4 mg or 2 mg of the drug have been available for years. Naloxone is also available in intranasal formulations for the same indication (see Table 1).

On April 29, the NIH recommended against use of the antiparasitic drug ivermectin for treatment of COVID-19 outside of a clinical trial. The recommendation was made because recent randomized, placebo-controlled trials of ivermectin have produced negative results and because alternative drugs that have been shown to be effective for treatment of COVID-19 are available.

The oral gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix (Orgovyx – Myovant Sciences/Pfizer) has been approved by the FDA for treatment of advanced prostate cancer in adults. It is the first oral GnRH receptor antagonist to become available in the US; degarelix (Firmagon), an injectable GnRH receptor antagonist, has been available since 2008 for the same indication.

Eflapegrastim-xnst ((Rolvedon) [Spectrum]; previously called Rolontis), a granulocyte colony-stimulating factor (G-CSF) conjugated to an Fc fragment of human IgG4, has been approved by the FDA to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive chemotherapy that can cause clinically significant febrile neutropenia.

Concizumab (Alhemo – Novo Nordisk), a subcutaneously injected tissue factor pathway inhibitor (TFPI) antagonist, has been approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients ≥12 years old who have hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. It is the second TFPI antagonist to be approved in the US for treatment of hemophilia A or B; the TFPI antagonist marstacimab (Hympavzi) is approved for use in patients without inhibitors.

The FDA has approved perfluorohexyloctane ophthalmic solution (Miebo – Bausch+Lomb) for treatment of dry eye disease. Available only by prescription, Miebo is the first ophthalmic product to be approved in the US that specifically targets tear evaporation caused by meibomian gland dysfunction. An ophthalmic solution with a similar name, Meibo Tears (Vista), which contains 0.6% propylene glycol, is available over the counter for dry eye relief.

The FDA has approved Omlonti (Ocuvex), a 0.002% ophthalmic solution of the prostaglandin EP₂ receptor agonist omidenepag isopropyl, for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Omidenepag is the first selective prostaglandin EP₂ receptor agonist to be approved in the US. It has been available in Japan since 2018.

The FDA has approved Susvimo (Genentech), a refillable permanent ocular implant containing the vascular endothelial growth factor (VEGF) inhibitor ranibizumab, for treatment of neovascular (wet) age-related macular degeneration (nAMD) in patients who have previously responded to at least two intravitreal injections of a VEGF inhibitor. Ranibizumab intravitreal injection (Lucentis) has been available since 2006 for monthly treatment of nAMD. The FDA has approved ranibizumab-nuna (Byooviz), a biosimilar of Lucentis and the first ophthalmologic biosimilar; it will be available in June...