The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupilumab is the first biologic drug to be approved in the US for this indication. It has been available for years for treatment of asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis.

Mepolizumab (Nucala – GSK), a subcutaneously injected interleukin-5 (IL-5) antagonist, has been approved by the FDA for add-on maintenance treatment of adults who have inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. Mepolizumab is also approved for treatment of asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.

The recombinant interleukin-1 (IL-1) receptor antagonist anakinra (Kineret – Sobi) has been granted an FDA Emergency Use Authorization (EUA) for treatment of hospitalized adults with confirmed COVID-19 pneumonia who require low- or high-flow supplemental oxygen, are at risk of progressing to severe respiratory failure, and are likely to have elevated plasma levels of soluble urokinase plasminogen activator receptor (suPAR). Anakinra has been available in the US for years; it is FDA-approved for multiple indications, including rheumatoid arthritis. Assays for suPAR are...

Fezolinetant (Veozah – Astellas), a first-in-class neurokinin 3 (NK3) receptor antagonist, has been approved by the FDA for treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the second nonhormonal treatment to be approved in the US for this indication; a low-dose formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate (Brisdelle) was approved in 2013.

The FDA has approved garadacimab-gxii (Andembry – CSL Behring), a subcutaneously injected inhibitor of activated clotting factor XII, for prevention of hereditary angioedema (HAE) attacks in patients ≥12 years old. Garadacimab is the first activated factor XII inhibitor to become available in the US for HAE prophylaxis

On January 3, the FDA amended its Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) to incorporate the following changes. The anti-SARS-CoV-2 antibody combinations casirivimab plus imdevimab (REGEN-COV) and bamlanivimab plus etesevimab are not active against the Omicron variant of SARS-CoV-2.

Treatment of community-acquired pneumonia (CAP) is usually empiric, with selected antibiotic regimens directed against some of the most common causative pathogens. Recommended empiric regimens are listed in Table 2; recommended antibiotic dosages for treatment of CAP are listed in Tables 3 and 4. Joint guidelines for treatment of CAP by the American Thoracic Society and the Infectious Diseases Society of America (ATS/IDSA) were updated in 2019.

Pharmacologic management of chronic heart failure (HF) is primarily determined by the patient's left ventricular ejection fraction (LVEF) and severity of symptoms. Patients with chronic HF who have an LVEF ≤40% are considered to have heart failure with reduced ejection fraction (HFrEF) and those with an LVEF ≥50% are considered to have heart failure with preserved ejection fraction (HFpEF). Patients with an LVEF of 41-49% have heart failure with mildly reduced or mid-range ejection fraction.

View the Comparison Chart: Some Drugs for HFrEF

The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include use of the vaccine as a two-dose primary series in adolescents 12-17 years old. The vaccine was authorized for primary immunization of adults in July 2022.