Seladelpar (Livdelzi – Gilead), a peroxisome proliferator-activated receptor (PPAR)-delta agonist, has received accelerated approval from the FDA for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso Forte, and generics) for treatment of primary biliary cholangitis (PBC) in adults who had an inadequate response to UDCA and as monotherapy in those unable to tolerate UDCA. Accelerated approval was based on a reduction in alkaline phosphatase (ALP) levels. Seladelpar is the second PPAR agonist to be approved in the US for this indication; elafibranor (Iqirvo)...

The FDA has approved a higher-dose intranasal naloxone formulation (Kloxxado – Hikma) for emergency treatment of opioid overdose. A single spray of the new formulation delivers 8 mg of naloxone; a formulation that delivers 4 mg per spray (Narcan) was approved in 2015.

Adagrasib (Krazati – Mirati Therapeutics), a RAS GTPase family inhibitor, has received accelerated approval from the FDA for oral treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who received at least one prior systemic therapy. Accelerated approval was based on the objective response rate and duration of response.

In our article on Drugs for Chronic Insomnia, we said there is little evidence that antidepressants such as trazodone, mirtazapine, or amitriptyline are effective in treating insomnia not associated with depression. We received a comment from a reader who has prescribed the tricyclic antidepressant amitriptyline for insomnia, particularly for patients with headache disorders, and finds that most patients are satisfied with the treatment.

The FDA has approved the oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq – Abbvie) for treatment of moderately to severely active ulcerative colitis in adults who have had an inadequate response to or cannot tolerate one or more tumor necrosis factor (TNF) inhibitors. Upadacitinib is the second JAK inhibitor to be approved for this indication; tofacitinib (Xeljanz) was the first. Upadacitinib is also approved for treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, and ankylosing spondylitis.

Nemolizumab (Nemluvio – Galderma), a subcutaneously injected interleukin-31 (IL-31) receptor antagonist, has been approved by the FDA for use in combination with topical corticosteroids and/or calcineurin inhibitors for treatment of moderate to severe atopic dermatitis in patients ≥12 years old whose disease is not adequately controlled with topical prescription drugs. It is the first IL-31 receptor antagonist to be approved in the US for this indication. Nemolizumab was approved earlier for treatment of prurigo nodularis in adults.

The FDA has approved a higher-dose injectable formulation of the long-acting glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Ozempic) for treatment of type 2 diabetes in adults. A single SC injection of the new 8 mg/3 mL formulation delivers 2 mg of semaglutide.

Tapinarof 1% cream (Vtama – Dermavant), an aryl hydrocarbon receptor (AhR) agonist, has been approved by the FDA for topical treatment of atopic dermatitis in patients ≥2 years old. Tapinarof is the first AhR agonist to be approved in the US for this indication. It was approved in 2022 for treatment of plaque psoriasis in adults.

Teplizumab-mzwv (Tzield – Provention Bio), an anti-CD3 monoclonal antibody, has been approved by the FDA to delay the onset of stage 3 type 1 diabetes in patients ≥8 years old who have stage 2 type 1 diabetes. It is the first drug to become available in the US that delays the onset of type 1 diabetes.

The FDA has approved Cobenfy (BMS), an oral fixed-dose combination of the muscarinic agonist xanomeline and the peripheral muscarinic antagonist trospium chloride, for treatment of schizophrenia in adults. It is the first antipsychotic drug to be approved in the US for treatment of schizophrenia that does not block dopamine receptors. This is the first approval for xanomeline; trospium has been available for many years for treatment of overactive bladder.