The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga – AstraZeneca) was approved by the FDA in 2020 to reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF). The indication has now been expanded to include a reduction in the risk of urgent HF visits and use in adults with any left ventricular ejection fraction (LVEF).

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.

Several large European observational studies published on-line this summer have raised questions about whether use of insulin glargine increases the risk of cancer.

The cardiovascular safety of the thiazolidinedione rosiglitazone (Avandia – GlaxoSmithKline) is in the news again, with some authorities calling for its removal from the market (New York Times, February 19, 2010).

Teplizumab-mzwv (Tzield – Provention Bio), an anti-CD3 monoclonal antibody, has been approved by the FDA to delay the onset of stage 3 type 1 diabetes in patients ≥8 years old who have stage 2 type 1 diabetes. It is the first drug to become available in the US that delays the onset of type 1 diabetes.

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy), which was approved by the FDA in 2021 for chronic weight management in adults, has now been approved for chronic weight management in children ≥12 years old with an initial BMI in the ≥95th percentile for age and sex.Semaglutide is also available as Ozempic and Rybelsus for treatment of type 2 diabetes in adults.

The thiazolidinediones rosiglitazone (Avandia) and pioglitazone (Actos) are peripheral insulin sensitizing agents used to treat hyperglycemia in patients with type 2 diabetes; one or the other is often used as a second or third agent with metformin (Glucophage, and others) and/or a sulfonylurea such as glimepiride (Amaryl, and others). A recent report suggested that rosiglitazone may increase the incidence of myocardial infarction (MI) and cardiovascular mortality.

The FDA has approved glucagon nasal powder (Baqsimi – Lilly) for treatment of severe hypoglycemia in patients ≥4 years old with diabetes. Baqsimi is the first noninjectable glucagon formulation to become available in the US. Injectable glucagon emergency kits (GlucaGen Hypokit, and generic) have been available for years, but they require reconstitution of the lyophilized powder by the caregiver immediately before injection. An injectable glucagon formulation that does not require reconstitution was recently approved by the FDA (Gvoke) and is expected to become available...

Insulin glulisine (Apidra - Sanofi Aventis) is the third rapid-acting insulin analog to be marketed in the US, following insulin lispro (Humalog) and insulin aspart (Novolog). All three have a more rapid onset and shorter duration of action than regular human insulin. Rapid-acting insulin analogs are generally taken immediately before meals and are usually combined with a long-acting basal insulin.

The FDA has approved Durlaza (New Haven Pharmaceuticals), a 24-hour extended-release (ER) aspirin formulation available only by prescription, for secondary prevention of myocardial infarction (MI) and stroke.