Colchicine (Colcrys, and others), which has been available in the US for decades for prophylaxis and treatment of gout flares and other indications in oral formulations that contain 0.6 mg of the drug, has now been approved in 0.5-mg tablets as Lodoco (Agepha) to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adults with established atherosclerotic disease or multiple risk factors for cardiovascular disease.

The FDA has approved the oral tyrosine kinase inhibitor repotrectinib (Augtyro – BMS) for treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. Repotrectinib is the third oral tyrosine kinase inhibitor to be approved for this indication in the US; crizotinib (Xalkori) and entrectinib (Rozlytrek) were approved earlier.

The FDA has approved evinacumab-dgnb (Evkeeza – Regeneron), an angiopoietin-like 3 (ANGPTL3) inhibitor, for adjunctive IV treatment of homozygous familial hypercholesterolemia (HoFH) in patients ≥12 years old. Evinacumab is the first ANGPTL3 inhibitor to be approved in the US.

The FDA has approved the complement C3 inhibitor pegcetacoplan (Syfovre – Apellis) for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Given as a series of monthly or every-other-month (EOM) intravitreal injections, it is the first drug to become available for use in patients with atrophic dry AMD. Subcutaneous pegcetacoplan was approved earlier as Empaveli for treatment of paroxysmal nocturnal hemoglobinuria.

The FDA has approved the complement C5 inhibitor avacincaptad pegol (Izervay – Iveric) for intravitreal treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Avacincaptad pegol is the second complement inhibitor to be approved in the US for this indication; pegcetacoplan (Syfovre), a complement C3 and C3b inhibitor, was approved earlier.

The FDA has approved the nitrofuran antiprotozoal drug nifurtimox (Lampit – Bayer) for treatment of Chagas disease (American trypanosomiasis) in children who weigh ≥2.5 kg. Nifurtimox was previously available in the US only through a CDC-sponsored Investigational New Drug (IND) program.

View the Comparison Table: Some Drugs for Plaque Psoriasis

Berotralstat (Orladeyo – Biocryst), an oral plasma kallikrein inhibitor, has been approved by the FDA for prevention of hereditary angioedema (HAE) attacks in adults and children ≥12 years old. The subcutaneously-injected plasma kallikrein inhibitor lanadelumab-flyo (Takhzyro) and the human plasma-derived C1 esterase inhibitors (C1INHs) Cinryze, which is given IV, and Haegarda, which is given SC, have been available for prophylaxis of HAE for years.

Primary hypothyroidism is usually the result of Hashimoto's (autoimmune) thyroiditis, thyroidectomy, or radioactive iodine therapy. Treatment of hypothyroidism with replacement doses of thyroid hormone is usually lifelong. Levothyroxine (LT4; synthetic thyroxine; Synthroid, and others) is the drug of choice.1

Consumption of alcohol has increased during the COVID-19 pandemic. The Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) defines alcohol use disorder (AUD; previously called alcohol dependence) as meeting ≥2 of the 11 criteria listed in Table 1 in the past year. The lifetime prevalence of AUD in the US population has been estimated to be about 30%. Despite this high prevalence and the associated morbidity, mortality, and costs, only 3 drugs are FDA-approved for treatment of the disorder.