7 Drugs Approved for Primary Care: Q4 2024
An oral antibiotic for drug-resistant UTIs, a long-awaited therapy for congenital adrenal hyperplasia, and more.
Urinary tract infection (UTI): Sulopenemetzadroxil and probenecid (Orlynvah®), is a penem antibacterial and renal tubular transport inhibitor combination indicated for the treatment of uncomplicated UTI caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. (Approved 10/25/24, Iterum Therapeutics plc)
For full prescribing information, please click here.
Type 2 diabetes (T2D): Liraglutide subcutaneous injection, is the first-time generic approval for Victoza® (Approved 12/23/24, Hikma Pharmaceuticals USA Inc.)
Atopic dermatitis: Tapinarof (Vtama®) cream, 1%, is an aryl hydrocarbon receptor agonist that received an additional indication for the topical treatment of atopic dermatitis in adults and children aged 2 years and older. It was originally approved in 2022 for the treatment of plaque psoriasis in adults. (Approved 12/12/24, Dermavant Sci)
For full prescribing information, please click here.
Obstructive sleep apnea (OSA): Tirzepatide (Zepbound®) injection, is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist that received a new indication for the treatment moderate to severe OSA in adults with obesity in combination with a reduced-calorie diet and increased exercise. Tirzepatide is the first and only prescription medication to receive approval for OSA and obesity. It was originally approved in 2023 to reduce excess body weight and maintain long-term weight reduction in adults with obesity or overweight with at least 1 weight-related comorbidity. (Approved 12/20/24, Eli Lilly & Co)
For full prescribing information, please click here.
Congenital adrenal hyperplasia (CAH): Crinecerfont (Crenessity®), is a first-in-class selective corticotropin-releasing factor type 1 (CRF-1) receptor antagonist indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and children aged 4 years and older with classic CAH. (Approved 12/13/24, Neurocrine Biosciences, Inc.)
For full prescribing information, please click here.
Inflammatory diseases: Ustekinumab-kfce (Yesintek®) injection, is a human interleukin-12 and -23 antagonist biosimilar to Stelara® (ustekinumab) that is indicated for the treatment of adults with moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn disease, or moderately to severely active ulcerative colitis. It is also indicated for the treatment of children aged 6 years and older with moderate to severe PsO, who are candidates for phototherapy or systemic therapy, or active psoriatic arthritis. (Approved 11/29/24, Biocon Biologics Inc)
For full prescribing information, please click here.
Atopic dermatitis: Nemolizumab (Nemluvio®), is a novel interleukin-31 receptor antagonist indicated for the treatment of adults and children aged 12 years and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. The recommended dosage is an initial dose of 60 mg, followed by 30 mg given every 4 weeks. In August 2024, the FDA approved nemolizumab as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis. (Approved 12/13/24, Galderma Labs)
For full prescribing information, please click here.
The fourth quarter has come and gone, which means Patient Care Online has compiled another list of drugs approved by the US FDA for conditions that are often seen in primary care. In the slides above, find details on a new treatment for obstructive sleep apnea in patients with obesity, an oral antibiotic for drug-resistant urinary tract infections, a long-awaited therapy for congenital adrenal hyperplasia, and 4 more.
For more information on key FDA approvals from 2024, check out:
