The sNDA was based on data from the landmark phase 3, randomized, double-blind, placebo-controlled DAPA-HF trial that evaluated the efficacy of dapagliflozin plus standard of care therapy for the prevention of CV death or reduction of HF events.
A Prescription Drug User Fee Act (PDUFA) target date of July 13, 2020 has been assigned to the application.
Increased risk of atrial fibrillation and bleeding with Vascepa observed in cardiovascular outcomes trial.
The FDA has expanded the indication for Toujeo (insulin glargine; Sanofi) 300 Units/mL to include treatment of pediatric patients aged ≥6 years with diabetes mellitus.
The warning letter described receipt of adulterated drugs from manufacturers with CGMP violations in 2018.
Integrated, pooled efficacy data from the phase 2 and phase 3 OPTIC trials of teprotumumab (Horizon Therapeutics) found that the treatment led to significant reductions in inflammation, proptosis (eye bulging) and diplopia (double vision) in patients with active thyroid eye disease (TED).
Bayer announced the submission of a supplemental New Drug Application to the Food and Drug Administration (FDA) for the intrauterine device.
The FDA has expanded the indication for Fiasp (insulin aspart injection; Novo Nordisk) 100 Units/mL to include use in insulin infusion pumps to improve glycemic control in adults with type 1 or type 2 diabetes.
The FDA has approved a new indication for Invokana (canagliflozin; Janssen) to reduce the risk of end-stage renal disease, doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure (HF) in adults with type 2 diabetes (T2D) and diabetic nephropathy with albuminuria >300mg/day.
Full detailed data will be presented at the AHA Scientific Sessions in Philadelphia in November 2019.
