Oral Semaglutide NDAs Seeking T2D Indication, CV Risk Reduction
Novo Nordisk has submitted 2 New Drug Applications (NDAs) for oral semaglutide as well as a supplemental NDA (sNDA) for subcutaneous (SC) semaglutide (glucagon-like peptide-1; Ozempic).
Endocrine Disorders
Clinical Outcomes Compared With Generics, Brand-Name Drugs for Chronic Conditions
An analysis of data from over 3.5 million patients found comparable clinical outcomes among patients who initiated generics vs those who were treated with brand-name drugs for chronic conditions such as diabetes, hypertension, osteoporosis, depression and anxiety.
Raspberries May Aid Glucose Control With Prediabetes
Eating red raspberries may help with glucose control in people with prediabetes.
Adding Semaglutide to SGLT-2 Inhibitor Tx Improves Glycemic Control, Reduces Body Weight in T2D
According to results from the SUSTAIN trial, the addition of semaglutide, a glucagon-like peptide-1 receptor agonist, to a sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy led to significant improvements in glycemic control, as well as weight reduction, in patients with inadequately controlled type 2 diabetes.
Authorized Generic of Humalog Soon to Be Available at Reduced Price
Eli Lilly announced plans to launch an authorized generic version of Humalog (insulin lispro) 100 Units/mL at a 50% lower list price.
Soliqua 100/33 Indication Expanded to Include T2D Patients Uncontrolled on Oral Antidiabetic Agents
The Food and Drug Administration (FDA) has approved an expanded indication for Soliqua 100/33 to include use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are uncontrolled on oral antidiabetic agents, in addition to those inadequately controlled on basal insulin or lixisenatide.
Farxiga, Xigduo XR Labeling Updated to Include Use in T2D Patients With Moderate Renal Impairment
The Food and Drug Administration (FDA) has approved updated labeling for Farxiga (dapagliflozin; AstraZeneca) and Xigduo XR (dapagliflozin and metformin HCl extended-release; AstraZeneca) to expand the use of these products in type 2 diabetes patients with moderate renal impairment.
Liquid Levothyroxine Formulation Now Available to Treat Hypothyroidism
Tirosint-SOL (levothyroxine sodium oral solution) has been made available by IBSA Pharma for the treatment of hypothyroidism and pituitary thyrotropin suppression.
First Alternate Controller Enabled Insulin Pump FDA-Cleared
Tandem Diabetes Care announced that the Food and Drug Administration (FDA) has authorized the t:slim X2 insulin pump with interoperable technology, the first of the Alternate Controller Enabled Infusion Pumps.
Linagliptin Non-Inferior to Glimepiride in Long-Term Cardiovascular Outcome Study
Boehringer Ingelheim and Lilly announced that the CAROLINA trial met its primary endpoint, demonstrating no increased cardiovascular (CV) risk with linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, when compared with glimepiride, a sulfonylurea, in patients with type 2 diabetes and CV risk.
