Captopril (Capoten - Bristol-Myers Squibb), an angiotensin-converting enzyme (ACE) inhibitor previously available for treatment of hypertension, has now been approved by the US Food and Drug Administration (FDA) for treatment of diabetic nephropathy in patients with insulin-dependent diabetes mellitus (IDDM). Diabetic nephropathy is the most common cause of end-stage renal disease in the United States.

In the Medical Letter article on ustekinumab (Stelara) for psoriasis (2010; 52:7), footnote 2 in table 2 should have included a second sentence: $5595.60 is the cost of one 45-mg syringe.

The FDA has approved the interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) for treatment of moderate to severe plaque psoriasis in adults. Risankizumab is the third IL-23 antagonist to be approved for this indication; guselkumab (Tremfya) and tildrakizumab (Ilumya) were approved earlier.

Fluvastatin (Lescol - Sandoz), an HMG-CoA reductase inhibitor, was recently marketed in the USA for treatment of hypercholesterolemia. A synthetic mevalonolactone derivative, it is chemically distinct from previously available drugs in this class.

The FDA has approved fidaxomicin (Dificid – Optimer), a new oral macrolide antibiotic, for treatment of Clostridium difficile-associated diarrhea in patients ≥18 years old. The incidence and severity of C. difficile infection (CDI) have increased in recent years with the emergence of an epidemic hypervirulent strain (NAP1/B1/027), possibly related to widespread use of fluoroquinolones.

The FDA has approved the somatostatin analog pasireotide diaspartate (Signifor – Novartis) for treatment of adults with Cushing's disease (cortisol excess caused by an ACTH-secreting pituitary tumor) who are not candidates for pituitary surgery or for whom surgery has not been curative. Pasireotide is the first drug approved in the US specifically to treat Cushing's disease. The antiprogestin mifepristone (Korlym) was approved last year for control of hyperglycemia in patients with Cushing's syndrome, which includes other causes of hypercortisolism, such as exogenous steroids and...

Omalizumab (Xolair) is a recombinant humanized monoclonal anti-IgE antibody currently approved by the FDA for treatment of moderate to severe persistent allergic asthma. It has been used off-label for treatment of allergic rhinitis and food allergies. Recently the results of a phase III clinical trial indicated that omalizumab may be effective in treating chronic urticaria as well.

New guidelines from The National Cholesterol Education Program recommend, as a therapeutic option, lowering treatment goals for LDL cholesterol (LDL-C) from <100 mg/dL to <70 mg/dL for patients at very high risk for coronary heart disease and from 130 mg/dL to <100 mg/dL for those at moderately high risk. A likely consequence of these recommendations is increased use of statins and use of higher doses with a concomitant increase in adverse effects.

The FDA has approved lebrikizumab-lbkz (Ebglyss – Lilly), a subcutaneously injected interleukin (IL)-13 antagonist, for treatment of moderate to severe atopic dermatitis that has not been or cannot be adequately treated with topical therapy in patients ≥12 years old (weight ≥40 kg). Lebrikizumab is the third subcutaneously injected human IgG4 monoclonal antibody to be approved in the US for this indication. Tralokinumab (Adbry), another IL-13 antagonist, is also approved for use in patients ≥12 years old, and dupilumab (Dupixent), an IL-4 and IL-13 inhibitor, is approved for...

The US Food and Drug Administration (FDA) has approved two new retinoids for treatment of psoriasis. Tazarotene gel 0.05% and 0.1% (Tazorac - Allergan) is being marketed for topical use in patients with stable, mild to moderate plaque psoriasis. Acitretin (Soriatane - Roche) is being promoted for systemic use in severe psoriasis.