FDA approves two new T2DM treatments
The FDA approved two new combination treatments for adults with type 2 diabetes mellitus (T2DM): Sanofi's once-daily Soliqua 100/33 (insulin glargine 100 units/mL and lixisenatide 33 mcg/mL injection) and Novo Nordisk's Xultophy 100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection). Both drugs contain fixed doses of a long-acting insulin and a glucagon-like peptide-1 (GLP-1) receptor agonist.
Soliqua 100/33 is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2DM who are inadequately controlled on basal insulin or lixisenatide. Soliqua 100/33 is delivered as a subcutaneous injection in a single, prefilled pen for once-daily dosing.
Soliqua 100/33 has not been studied with short-acting insulin or in patients with a history of pancreatitis. The drug should be stopped if pancreatitis is suspected and should not be restarted if pancreatitis is confirmed. It is not known if it is safe and effective in children under age 18. The drug is not for use in patients with type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or for those who have gastroparesis.
Xultophy 100/3.6 is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2DM who are inadequately controlled on basal insulin or liraglutide. Xultophy 100/3.6 is taken once daily at the same time each day as a subcutaneous injection with or without food and is available in a prefilled pen. The drug is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or if the patient has multiple endocrine neoplasia syndrome type 2. It is not known if the medication is safe and effective for use in children under age 18.
Xultophy 100/3.6 is not recommended for patients with a history of pancreatitis. The drug should be stopped if pancreatitis is suspected and should not be restarted if pancreatitis is confirmed. Xultophy 100/3.6 is not recommended for use in patients with T1DM or ketoacidosis.
FDA approves expanded indication for FluLaval Quadrivalent vaccine
The FDA approved an expanded indication for FluLaval Quadrivalent influenza vaccine to include use in children 6 months and older. Previously, the vaccine was approved only for active immunization against influenza A subtype viruses and type B viruses in children age 3 and older. FluLaval Quadrivalent is a product of GSK.
The expanded age indication allows providers to vaccinate all recommended patients age 6 months and older. The vaccine is contraindicated in patients with a history of severe allergic reaction to any component of the vaccine, including egg protein.
Expanded approval for empagliflozin to reduce cardiovascular death
Boehringer Ingelheim received FDA approval for an expanded indication for empagliflozin (Jardiance) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus (T2DM) and cardiovascular disease. The FDA's decision was based on a postmarketing study the agency requested after it approved empagliflozin in 2014 as an adjunct to diet and exercise to improve glycemic control in adults with T2DM. The trial showed that empagliflozin reduced the risk of cardiovascular death compared with placebo when added to standard-of-care therapies for diabetes mellitus and atherosclerotic cardiovascular disease.
The most common adverse reactions of empagliflozin are urinary tract infections (UTIs) and female genital infections. It is not intended for use by patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
The FDA cautions that empagliflozin can cause dehydration and hypotension and can cause ketoacidosis, serious UTIs, acute kidney injury, and impairment in kidney function, hypoglycemia when used with insulin or insulin secretagogues, vaginal yeast infections, genital mycotic infections, and increased cholesterol. Empagliflozin is contraindicated in patients with severe kidney impairment, end-stage kidney disease, and those on dialysis.