The FDA has approved Kimyrsa (Melinta), a new IV formulation of the long-acting lipoglycopeptide antibiotic oritavancin, for treatment of adults with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria. Orbactiv (Melinta), another IV formulation of oritavancin, was approved in 2014 for the same indication. Kimyrsa has a smaller infusion volume (250 mL vs 1 L) and a shorter infusion time (1 hour vs 3 hours) compared to Orbactiv (see Table 1).

The FDA has required the addition of information about an increased risk of nonmelanoma skin cancer (basal cell carcinoma [BCC] and squamous cell carcinoma [SCC]) to the labels of products containing the diuretic hydrochlorothiazide.

Excessive exposure to ultraviolet (UV) radiation can cause erythema, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but questions remain about their effectiveness and safety. In 2021, the FDA proposed a rule that would require additional safety studies for some sunscreen active ingredients and mandate better UVA protection in sunscreen products.

The Centers for Disease Control and Prevention (CDC) and the Environmental Protection Agency (EPA) recommend using insect repellents to avoid being bitten by mosquitoes, ticks, and other arthropods that transmit disease-causing pathogens. Repellents applied to exposed skin should be used in conjunction with other preventive measures such as wearing long-sleeved shirts, pants, and socks and avoiding outdoor activities during peak mosquito-biting times. Some insect repellents are listed in Table 1.

In June 2021, the FDA approved the IV amyloid beta-directed monoclonal antibody aducanumab (Aduhelm) for treatment of Alzheimer’s disease. The approval did not restrict use of the drug to patients with mild cognitive impairment or mild dementia, which was the population enrolled in the clinical trials. Now, Biogen, with the permission of the FDA, has made an addition to the labeling of the drug that says: Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical...

Ceftobiprole medocaril sodium (Zevtera – Innoviva Specialty Therapeutics), a new IV cephalosporin antibacterial drug, has been approved by the FDA for treatment of Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSIs), and community-acquired bacterial pneumonia (CABP) (see Table 1). It is the second cephalosporin with activity against methicillin-resistant S. aureus (MRSA) to be approved in the US; ceftaroline (Teflaro), which was approved for treatment of ABSSSIs and CABP in 2010, was the...

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.

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.

Epsolay (Galderma), a 5% benzoyl peroxide cream, has been approved by the FDA for treatment of inflammatory lesions of rosacea in adults. It is the first product containing benzoyl peroxide to be approved in the US for treatment of rosacea. Benzoyl peroxide formulations approved for acne have been used off-label to treat rosacea for years, but itching and burning have limited their use.

View the Comparison Chart: Interleukin (IL) Receptor Antagonists for Atopic Dermatitis