Concizumab (Alhemo – Novo Nordisk), a subcutaneously injected tissue factor pathway inhibitor (TFPI) antagonist, has been approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients ≥12 years old who have hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. It is the second TFPI antagonist to be approved in the US for treatment of hemophilia A or B; the TFPI antagonist marstacimab (Hympavzi) is approved for use in patients without inhibitors.

Radicava ORS, an oral suspension formulation of the free radical scavenger edaravone (Mitsubishi Tanabe Pharma), has been approved by the FDA for treatment of amyotrophic lateral sclerosis (ALS). An IV formulation of edaravone (Radicava) has been available since 2017.

Drugs for gout are used to reduce the pain and inflammation of acute flares, decrease the frequency of exacerbations, and lower serum urate levels to prevent recurrent flares, development of tophi, and joint damage.

The FDA has approved viloxazine extended-release capsules (Qelbree – Supernus) for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-17 years old. Viloxazine is the second selective norepinephrine reuptake inhibitor to be approved in the US for treatment of ADHD; atomoxetine (Strattera, and generics) was approved in 2002.

The FDA has approved the second-generation antipsychotic drug lumateperone (Caplyta — Intra-Cellular Therapies) for adjunctive treatment of major depressive disorder (MDD) in adults. Lumateperone was approved earlier for treatment of schizophrenia and bipolar depression.

Anxiety disorders (generalized anxiety disorder, panic disorder, social anxiety disorder, and various phobias) are the most common form of psychiatric illness. They can be treated effectively with cognitive behavioral therapy (CBT) and/or pharmacotherapy.

The FDA has approved Vizz (Lenz Therapeutics), a 1.44% ophthalmic solution of the cholinergic agonist aceclidine, for treatment of presbyopia in adults. Aceclidine has been available in the EU for years for treatment of open-angle glaucoma.

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

The interleukin-6 (IL-6) receptor antagonist tocilizumab (Actemra – Genentech) has received an Emergency Use Authorization (EUA) from the FDA for IV treatment of COVID-19 in hospitalized patients ≥2 years old who are receiving a systemic corticosteroid and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Tocilizumab has been approved by the FDA for various indications, including rheumatoid arthritis and juvenile idiopathic arthritis.

The FDA has approved deucravacitinib (Sotyktu – BMS), an oral tyrosine kinase 2 (TYK2) inhibitor, for once-daily treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Deucravacitinib is the first selective TYK2 inhibitor to be approved in the US for any indication.