51˶

BI's Jardiance Finally Wins FDA Green Light

— The FDA has approved the SGLT2 inhibitor empagliflozin (Jardiance) for type 2 diabetes, the agency announced.

by Staff Writer, 51˶

MedpageToday
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This article is a collaboration between 51˶ and:

The FDA has finally okayed the SGLT2 inhibitor empagliflozin (Jardiance) for type 2 diabetes, .

Approval follows the results of seven clinical trials totaling 4,480 patients with type 2 diabetes, the pivotal trials of which showed that the drug outperformed placebo in improving glycemic control as measured with HbA1c, the agency said.

In March, the FDA told drugmaker Boehringer Ingelheim that the drug wouldn't be approved until the company fixed deficiencies at its manufacturing plant.

The agency is requiring four postmarketing studies of empagliflozin:

  • Completion of an ongoing cardiovascular outcomes trial
  • A pediatric pharmacokinetic/pharmacodynamic study
  • A pediatric safety and efficacy study, which will also look at bone health and development
  • A juvenile toxicity study in animals with a focus on renal development, bone development, and growth

In its press release, the FDA also warned that the drug can cause dehydration, leading to a drop in blood pressure that can result in dizziness and fainting, as well as a decline in renal function.

The elderly, patients with impaired renal function, and those on diuretics are more susceptible to this risk, the agency said.

Two other SGLT2 inhibitors, which work by prompting the kidneys to excrete glucose into the urine rather than reabsorb it, have previously been approved in the U.S.: canagliflozin (Invokana) and dapagliflozin (Farxiga).