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.

The FDA has approved a higher-dose injectable formulation of the opioid antagonist naloxone (Zimhi – Adamis) for emergency treatment of opioid overdose. A single IM or SC injection of the new formulation delivers 5 mg of naloxone; injectable formulations that deliver 0.4 mg or 2 mg of the drug have been available for years. Naloxone is also available in intranasal formulations for the same indication (see Table 1).

Mosunetuzumab-axgb (Lunsumio – Genentech), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of relapsed or refractory follicular lymphoma in adults who received ≥2 lines of systemic therapy. It is the first T-cell-engaging bispecific antibody to be approved in the US for this indication.

Elranatamab-bcmm (Elrexfio – Pfizer), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, has been granted accelerated approval by the FDA for treatment of relapsed or refractory multiple myeloma in adults who received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Accelerated approval was based on the response rate and durability of response. Elranatamab is the second bispecific BCMA-directed CD3 T-cell engager to be approved for this indication; teclistamab (Tecvayli) was the...

The FDA has approved Vtama (Dermavant), a 1% cream formulation of the aryl hydrocarbon receptor (AhR) agonist tapinarof, for treatment of adults with plaque psoriasis. It is the first AhR agonist to be approved by the FDA.

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...

Eohilia (Takeda), an oral suspension formulation of the corticosteroid budesonide, has been approved by the FDA for treatment of eosinophilic esophagitis (EoE) in patients ≥11 years old. It is the first oral drug to be approved in the US for this indication. The subcutaneously injected interleukin (IL)-4 receptor antagonist dupilumab (Dupixent) is approved for treatment of EoE in patients ≥1 year old who weigh ≥15 kg.

Glofitamab-gxbm (Columvi – Genentech), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for IV treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, or large B-cell lymphoma (LBCL) arising from follicular lymphoma after ≥2 lines of systemic therapy. Accelerated approval was based on response rates and durability of response. Glofitamab is the second T-cell-engaging bispecific antibody to be approved in the US for treatment of DLBCL; epcoritamab-bysp (Epkinly), which is given...

Voclosporin (Lupkynis – Aurinia), an oral calcineurin inhibitor, has been approved by the FDA for use in combination with the antimetabolite immunosuppressant mycophenolate mofetil (Cellcept, and generics) and a corticosteroid for treatment of adults with active lupus nephritis. It is the first calcineurin inhibitor to be approved in the US for this indication. Tacrolimus (Prograf, and others) and cyclosporine (Neoral, and others), the other available systemic calcineurin inhibitors, are approved for prophylaxis of organ rejection in transplant patients.

The injectable interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) has been approved by the FDA for treatment of moderately to severely active Crohn's disease (CD) in adults. Risankizumab was approved earlier for treatment of plaque psoriasis and psoriatic arthritis.