Caplacizumab-yhdp (Cablivi – Sanofi /Genzyme), a von Willebrand factor-directed antibody fragment, has been approved by the FDA for use in combination with plasma exchange and immunosuppressive therapy for treatment of immune-mediated thrombotic thrombocytopenic purpura (iTTP; formerly called acquired thrombotic thrombocytopenic purpura [aTTP]) in adults. It is the first drug to be approved in the US for this indication.

On December 18, 2020, the FDA issued an Emergency Use Authorization (EUA) for the Moderna mRNA-based vaccine for prevention of COVID-19 in persons ≥18 years old. The Pfizer-BioNTech mRNA-based vaccine received an FDA EUA for the same indication in persons ≥16 years old on December 11, 2020.

Emrosi (Journey), an oral, low-dose, biphasic-release formulation of the tetracycline antibiotic minocycline, has been approved by the FDA for once-daily treatment of inflammatory lesions of rosacea (papules and pustules) in adults. Low-dose, biphasic-release doxycycline (Oracea, and generics) has been available for years for treatment of papulopustular rosacea.

The main goals of treatment of chronic obstructive pulmonary disease (COPD) are to relieve symptoms, reduce the frequency and severity of exacerbations, prevent disease progression, and reduce mortality. GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines for treatment of COPD were updated recently. Treatment of acute exacerbations is not discussed here. Drugs available for treatment of COPD are listed in Tables 1 and 3.

The CDC has issued new guidance allowing for an interval of up to 8 weeks between the first and second primary doses of an mRNA COVID-19 vaccine in certain patients 12-64 years old.1 Product labeling currently recommends a 3-week interval between the first two doses of the Pfizer/BioNTech mRNA vaccine (Comirnaty) and a 4-week interval between the first two doses of the Moderna mRNA vaccine (Spikevax). The new guidance is based on data suggesting that a longer interval can decrease the risk of myocarditis and may improve vaccine efficacy.

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.

View the COVID-19 Vaccine Comparison Chart

The FDA recently expanded the eligibility criteria (see Table 1) for treatment with the surgically implanted hypoglossal nerve stimulation system (Inspire Upper Airway Stimulation – Inspire Medical Systems). The device has been advertised lately on radio and television.

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 injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Ozempic – Novo Nordisk) has been approved by the FDA to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). It is the first GLP-1 receptor agonist to be approved in the US for this indication.