FDA News

FDA grants priority review of canagliflozin for CKD

James List

The FDA has granted priority review of a supplemental new drug application for Janssen’s Invokana for reducing the risk of ESKD in adults with type 2 diabetes and chronic kidney disease.

Janssen Pharmaceutical Companies said in a press release that if the FDA grants approval of a CKD indication for Invokana (canagliflozin), it will be the first and only drug to treat CKD in patients with type 2 diabetes.

“We are pleased the FDA recognizes the urgency to deliver a novel treatment that can reduce the risk of kidney failure and prevent life-threatening cardiovascular events in people with type 2 diabetes and chronic kidney disease,” James List, MD, PhD, global therapeutic area head of cardiovascular and metabolism at Janssen Research & Development LLC. “This priority review designation brings us one step closer to addressing this major unmet need and providing a new standard of care to those living with this serious condition.”

The application was submitted in March 2019 and was based on a phase 3 CREDENCE renal outcomes study, which was published in the New England Journal of Medicine. Priority review shortens the FDA review period to 6 months compared to 10 months for standard review.

The FDA most recently approved a new indication for Invokana in October 2018 to reduce the risk of major adverse cardiovascular events, including heart attack, stroke or death due to a cardiovascular cause in adults with type 2 diabetes who have established cardiovascular disease.

Reference:

www.janssen.com/us/news-center

 

 

James List

The FDA has granted priority review of a supplemental new drug application for Janssen’s Invokana for reducing the risk of ESKD in adults with type 2 diabetes and chronic kidney disease.

Janssen Pharmaceutical Companies said in a press release that if the FDA grants approval of a CKD indication for Invokana (canagliflozin), it will be the first and only drug to treat CKD in patients with type 2 diabetes.

“We are pleased the FDA recognizes the urgency to deliver a novel treatment that can reduce the risk of kidney failure and prevent life-threatening cardiovascular events in people with type 2 diabetes and chronic kidney disease,” James List, MD, PhD, global therapeutic area head of cardiovascular and metabolism at Janssen Research & Development LLC. “This priority review designation brings us one step closer to addressing this major unmet need and providing a new standard of care to those living with this serious condition.”

The application was submitted in March 2019 and was based on a phase 3 CREDENCE renal outcomes study, which was published in the New England Journal of Medicine. Priority review shortens the FDA review period to 6 months compared to 10 months for standard review.

The FDA most recently approved a new indication for Invokana in October 2018 to reduce the risk of major adverse cardiovascular events, including heart attack, stroke or death due to a cardiovascular cause in adults with type 2 diabetes who have established cardiovascular disease.

Reference:

www.janssen.com/us/news-center