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).

Etranacogene dezaparvovec-drlb (Hemgenix – CSL Behring), an adeno-associated virus vector-based gene therapy, has been approved by the FDA for treatment of hemophilia B in adults who currently receive factor IX prophylaxis therapy or have had life-threatening or repeated, serious, spontaneous bleeding episodes. It is the first gene therapy to be approved in the US for this indication.

The FDA has issued an Emergency Use Authorization (EUA) for the long-acting investigational IV monoclonal antibody pemivibart (Pemgarda – Invivyd) for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old (weight ≥40 kg) who have moderate to severe immune compromise and are unlikely to respond adequately to COVID-19 vaccination (see Table 1). Pemgarda is the only drug that is currently authorized in the US for pre-exposure prophylaxis of COVID-19. Tixagevimab/cilgavimab (Evusheld) was previously available under an EUA for this indication, but it lacks activity against...

The FDA has approved Exblifep (Allecra), a fixed-dose combination of the cephalosporin cefepime and the beta-lactamase inhibitor enmetazobactam, for IV treatment of adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by designated susceptible microorganisms (see Spectrum of Activity). Exblifep is the first product that contains enmetazobactam to be approved in the US.

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.

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.

View Expanded Table: Some Conventional DMARDs for Rheumatoid Arthritis

The FDA has approved Vuity (Abbvie), a 1.25% ophthalmic solution of the muscarinic receptor agonist pilocarpine hydrochloride, for treatment of presbyopia in adults. Pilocarpine 1%, 2%, and 4% ophthalmic solutions (Isopto Carpine, and others) have been available for years for treatment of glaucoma, but local and systemic adverse effects have limited their use.

The investigational monoclonal antibody bebtelovimab (LY-CoV1404 – Lilly) has been granted an FDA Emergency Use Authorization (EUA) for IV treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease, including hospitalization and death, and for whom alternative treatment options are unavailable or inappropriate. Bebtelovimab is active against the Omicron variant of SARS-CoV-2; sotrovimab (VIR-7831) is the only other monoclonal antibody currently available for treatment of COVID-19 that is active...

The injectable interleukin (IL)-23 antagonist risankizumab-rzza (Skyrizi – Abbvie), previously approved by the FDA for treatment of Crohn's disease (CD), has now been approved for treatment of moderately to severely active ulcerative colitis (UC) in adults. Risankizumab is the first IL-23 antagonist to be approved for treatment of both CD and UC. It is also approved for treatment of plaque psoriasis and psoriatic arthritis.