Donanemab-azbt (Kisunla – Lilly), an IV amyloid beta-directed monoclonal antibody, has been approved by the FDA for treatment of Alzheimer's disease (AD). The label states that the drug should only be started in patients with mild cognitive impairment (MCI) or mild dementia. Donanemab is the third IV amyloid beta-directed monoclonal antibody to be marketed in the US. Lecanemab (Leqembi – Biogen/Eisai) was approved by the FDA in 2023 for the same indication as donanemab. Aducanumab (Aduhelm – Lilly) was granted accelerated approval in 2021, but it was withdrawn from the market...

Donidalorsen (Dawnzera – Ionis), a subcutaneously injected prekallikrein-directed antisense oligonucleotide, has been approved by the FDA for prevention of hereditary angioedema (HAE) attacks in patients ≥12 years old. It is the first RNA-targeted drug to be approved in the US for this indication.

Yutrepia (Liquidia), a dry powder inhaler formulation of the prostacyclin analog treprostinil, has been approved by the FDA to improve exercise ability in adults with pulmonary arterial hypertension (PAH; WHO Group 1) or pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3). Tyvaso DPI, another treprostinil dry powder inhaler, was approved earlier for the same indication.

Aficamten (Myqorzo – Cytokinetics), an oral cardiac myosin inhibitor, has been approved by the FDA to improve functional capacity and symptoms in adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). It is the second cardiac myosin inhibitor to be approved in the US for this indication; mavacamten (Camzyos) was approved in 2022.

The FDA now requires that product labels for the long-acting injectable progestin contraceptive medroxyprogesterone acetate (MPA; Depo-Provera CI, and generics; Depo-SubQ Provera 104) include a warning about the risk of meningioma associated with its use.

View Comparison Table: Some Drugs for Maintenance Treatment of Opioid Use Disorder

The FDA has approved the oral kinase inhibitor quizartinib (Vanflyta – Daiichi Sankyo) for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy in adults with FLT3 internal tandem duplication (ITD)-positive, newly-diagnosed acute myeloid leukemia (AML).

Inclisiran (Leqvio – Novartis), a subcutaneously injected small interfering RNA (siRNA) that decreases LDL-cholesterol (LDL-C) levels by reducing synthesis of proprotein convertase subtilisin/kexin type 9 (PCSK9), has been approved by the FDA for use with or without a statin to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Inclisiran had previously been approved for use only in combination with statin therapy.

The FDA has approved Tonmya (Tonix), a sublingual tablet formulation of the skeletal muscle relaxant cyclobenzaprine, for treatment of fibromyalgia in adults. Cyclobenzaprine is available in immediate-release tablets and extended-release capsules for short-term treatment of muscle spasms and has been used off-label for treatment of fibromyalgia.

Sibeprenlimab (Voyxact – Otsuka), a subcutaneously injected cytokine A proliferation-inducing ligand (APRIL) blocker, has been granted accelerated approval by the FDA to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN; also called Berger's disease) who are at risk for disease progression. Sibeprenlimab is the first APRIL blocker to be approved in the US. Atacicept (Trutakna), a B-lymphocyte stimulator and APRIL blocker, was recently granted accelerated FDA approval for the same indication; it will be reviewed in a future issue.