Purchase Summary

In order to access content on the FENIX Marketplace, you must have an account. You will also have access to FENIX Free updates.

The price for access is $599.00.


Account Information Already have an account? Log in here

*
LEAVE THIS BLANK

Payment Information We Accept Visa, Mastercard, American Express and Discover

 

By selecting this, I agree to receive emails from fenix.group.


You will be redirected to view the full article after purchasing. You will receive your account and payment information in a confirmation email, and can be viewed at any time in your Account.

Farxiga DAPA-CKD Receives Priority Review from FDA

Here is a brief preview of this blast: AstraZeneca announced FDA granted Priority Review to Farxiga for the treatment of chronic kidney disease in patients with and without T2DM based on results from the DAPA-CKD study. Recall, FDA previously granted Breakthrough Therapy designation to Farxiga for CKD in October 2020 following positive results from the DAPA-CKD trial which were first presented at ESC 2020. Of note, AZ stated the PDUFA date will occur in Q2 '21. Below, FENIX provides a projected approval timeline for the impending DAPA-CKD regulatory review as well as readthrough to the SGLT2i class.

About The Author

Matthew Maryniak

|
President of Fenix Group International
Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.