The FDA has approved dupilumab (Dupixent – Sanofi/Regeneron), a subcutaneously-injected fully human monoclonal antibody, for treatment of adults with moderate to severe atopic dermatitis (eczema) that has not responded to topical therapies. It can be used with or without topical corticosteroids.

The FDA has approved intravenously administered recombinant von Willebrand factor (Vonvendi - Shire) for adults with von Willebrand disease (VWD) who require on-demand treatment and control of bleeding episodes. It is the first recombinant von Willebrand factor (VWF) product to become available in the US.

The FDA has approved brodalumab (Siliq – Valeant), an injectable human interleukin (IL)-17A receptor antagonist, for treatment of adults with moderate to severe plaque psoriasis who have failed to respond to other systemic therapies. Brodalumab is the third IL-17A antagonist to be approved in the US for this indication; secukinumab (Cosentyx) and ixekizumab (Taltz) were approved earlier.

The FDA has approved an extended-release (ER) capsule formulation of amantadine (Gocovri – Adamas) for once-daily treatment of levodopa-induced dyskinesia in patients with Parkinson's disease (PD). It is the first product to be approved in the US for this indication. Immediate-release (IR) amantadine has been used off-label for years to manage levodopa-induced dyskinesia.

The FDA has approved Qtern (AstraZeneca), a fixed-dose combination of the sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga) and the dipeptidyl peptidase-4 (DPP-4) inhibitor saxagliptin (Onglyza), for oral treatment of adults with type 2 diabetes. Dapagliflozin and saxagliptin have each been available for years alone and in combination with extended-release metformin (Xigduo XR; Kombiglyze XR). Three SGLT2/DPP-4 inhibitor combinations are now available in the US (see Table 2).

The FDA has approved prabotulinumtoxinA-xvfs (Jeuveau – Evolus) for temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity. Jeuveau is the fourth botulinum toxin product to be approved in the US for this indication (see Table 1). It has been available in South Korea as Nabota since 2014.

The FDA has approved Twirla (Agile Therapeutics), a transdermal contraceptive patch containing the estrogen ethinyl estradiol and the progestin levonorgestrel, for use in women with a BMI <30 kg/m². It is the second contraceptive patch to become available in the US; Xulane, a patch that delivers ethinyl estradiol and the progestin norelgestromin, has been available since 2014.

The centuries-old anti-inflammatory drug colchicine (Colcrys, and others) is FDA-approved for prophylaxis and treatment of gout flares and for treatment of familial Mediterranean fever. It is also used off-label to treat pericarditis, and in recent years has been investigated for reduction of cardiovascular risk in patients with coronary artery disease (CAD).

The IV antiviral drug remdesivir (Veklury – Gilead) has been available for treatment of COVID-19 in hospitalized patients since 2020. Now, the FDA has approved remdesivir for treatment of mild to moderate COVID-19 in outpatients ≥12 years old who weigh ≥40 kg and are at high risk for progression to severe disease, including hospitalization or death; they also issued an Emergency Use Authorization (EUA) allowing its use in any other high-risk outpatient who weighs ≥3.5 kg.

The FDA has approved a dextroamphetamine transdermal patch (Xelstrym – Noven) for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old. Xelstrym is the first transdermal amphetamine product to be approved in the US. A methylphenidate transdermal patch (Daytrana, and generics) has been available for years for treatment of ADHD.