The approval was based on data from an active-controlled, treat-to-target trial (Onset7) that included 777 pediatric patients (aged 2 to 17 years) with type 1 diabetes.
Novo Nordisk announced the launch of several new programs that are intended to improve insulin affordability for US patients. These programs include: My$99Insulin: Patients will be allowed to purchase up to 3 vials or 2 packs of FlexPen/FlexTouch/PenFill pens of any combination of Novo Nordisk insulins (ie, NovoLog, Novolog Mix 70/30, Levemir, Tresiba, Fiasp, Novolin…
The Food and Drug Administration (FDA)’s Dermatologic and Ophthalmic Drugs Advisory Committee voted in favor of the approval of teprotumumab (Horizon Therapeutics) for the treatment of thyroid eye disease.
The FDA is investigating metformin products in the US based on these reports; currently no metformin products have been recalled.
Egrifta SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.
Twice-yearly dosing with inclisiran sodium resulted in significant lowering of low-density lipoprotein cholesterol, according to results from the ORION-9 study.
Treatment with empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, was associated with reduced risk of hospitalization for heart failure when compared with use of dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide (GLP)-1 receptor agonists.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted in favor (16-0) to recommend the approval of Vascepa (icosapent ethyl capsules; Amarin) to reduce residual cardiovascular (CV) risk in patients with statin-managed low density lipoprotein (LDL) cholesterol, but persistent elevated triglycerides.