Jardiance bags FDA Fast Track designation

The US Food and Drug Administration (FDA) has granted Boehringer Ingelheim Fast Track designation for the investigation of Jardiance (empagliflozin).

The drug, which is being investigated to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease, addresses the "urgent need" for new treatment options for people living with the disease worldwide, many of whom are at risk of progressing to end-stage.

"Chronic kidney disease is a serious and highly prevalent condition, which affects nearly 700 million adults worldwide," said Waheed Jamal, corporate vice president and head of CardioMetabolic Medicine, Boehringer Ingelheim.

"This decision from the FDA demonstrates how important effective treatment options are for people with chronic kidney disease and the cardiovascular and metabolic disorders it is linked to."

Boehringer, who co-develop the drug with Eli Lilly, say that the decision follows a Jardiance Fast Track designation which was granted by the FDA in July 2019 for the risk of cardiovascular death and hospitalisation for heart failure in people with chronic heart failure.

The drug, an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor, is the first medicine approved by regulatory authorities to significantly reduce the risk of cardiovascular death or include data on the reduction of the risk of cardiovascular death in the label for adults with type II diabetes and established cardiovascular disease.

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