The erythropoiesis-stimulating agents (ESAs) epoetin alfa (Epogen, Procrit) and darbepoetin alfa (Aranesp) are widely used for treatment of anemia and to reduce the need for red blood cell transfusions. Based on the results of recent clinical trials indicating an increased risk of serious adverse events and death associated with ESAs, particularly when used to achieve a hemoglobin concentration ≥12 g/dL, the FDA has revised the prescribing information for these drugs to include a black box warning.

Six vaccines are recommended for routine use in adults living in the USA (Guide for Adult Immunization, 2nd ed, Philadelphia:American College of Physicians, 1990). Immunization recommendations for travel outside the USA were published in The Medical Letter, volume 32, page 33, April 6, 1990.

Givinostat (Duvyzat – Italfarmaco), an oral histone deacetylase inhibitor, has been approved by the FDA for treatment of patients ≥6 years old with Duchenne muscular dystrophy (DMD), regardless of the DMD-causing mutation. It is the first nonsteroidal drug to be approved for this indication. The oral corticosteroids deflazacort (Emflaza) and vamorolone (Agamree) are also approved for treatment of patients with all genetic variants of DMD.

The FDA has approved Jentadueto XR (Boehringer Ingelheim/Lilly), a once-daily extended-release formulation of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin and the biguanide metformin, for oral treatment of type 2 diabetes. Linagliptin and metformin have been available for years in a twice-daily immediate-release combination (Jentadueto). Once-daily extended-release formulations combining metformin with the DPP-4 inhibitors saxagliptin (Kombiglyze XR) and sitagliptin (Janumet XR) are also available.

The FDA has approved venetoclax (Venclexta – Abbvie/Genentech), an oral selective BCL-2 inhibitor, for treatment of chronic lymphocytic leukemia (CLL) in patients with a 17p deletion who have received at least one prior therapy. The 17p deletion is associated with a poor prognosis in patients with CLL; it is prevalent in about 20% of patients with relapsed CLL. Venetoclax is the fi rst BCL-2 inhibitor to become available in the US.

Liraglutide (Victoza – Novo Nordisk), a glucagon-like peptide-1 (GLP-1) receptor agonist given by subcutaneous injection, has been approved by the FDA for treatment of patients with type 2 diabetes. It can be used alone or in addition to oral antidiabetic drugs such as metformin (Glucophage, and others) or glimepiride (Amaryl, and others). Liraglutide is not recommended for first-line therapy and is not approved for use with insulin.

The FDA has approved oritavancin (Orbactiv – The Medicines Company), a long-acting lipoglycopeptide antibiotic given as a single intravenous (IV) dose, for treatment of acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria in adults. It is the third lipoglycopeptide antibiotic to be marketed in the US; telavancin (Vibativ) and dalbavancin (Dalvance) were approved earlier.

The androgen receptor inhibitor darolutamide (Nubeqa – Bayer) has been approved by the FDA for use in combination with docetaxel for treatment of metastatic hormone-sensitive prostate cancer (mHSPC). The drug was previously approved for treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC).

Pravastatin - Bristol-Myers Squibb) and simvastatin (Zocor -Merck), two new inhibitors of cholesterol synthesis similar to lovastatin (Mevacor - Merck), have now been marketed in the USA for treatment of hypercholesterolemia. Lovastatin (Medical Letter, 29:99, 1987) is the most frequently prescribed of all cholesterol-lowering drugs in the USA. Pravastatin and simvastatin were previously reviewed in The Medical Letter when they became available in Canada (volume 33, page 18, 1991).

The FDA has approved use of denosumab (Prolia – Amgen) for treatment of osteoporosis in postmenopausal women at high risk for fracture.