Some news we have been waiting on: FDA have approved Janssen (J&J) Invokana (Canafliglozin) for CKD & CVD in T2DM, & timing right on track for priority review for this indication. Application is pending in EU & also has been granted priority review.
From the below article, I think this sums up nicely the relevance for PIQ, particularly the collaboration with Janssen on analysing samples from the CREDENCE study that instigated this approval for CKD in T2DM:
"Given the nation's heightened focus on kidney health at the highest levels of government, this approval couldn't have come at a better time and offers real hope for patients with type 2 diabetes and diabetic kidney disease," said LaVarne A. Burton, President and Chief Executive Officer, American Kidney Fund.* "We know that the real battle to turn the tide on kidney disease is in early detection and slowing its progression so that patients stay healthier and fewer patients reach kidney failure. We are so grateful that advances in kidney disease research are producing treatment options that help to slow the progression of diabetic kidney disease and reduce the risk of hospitalization for heart failure."
So I agree with the question “Where to from here”, because this is now a whole new ball game for CKD in T2DM with a drug now available to help prevent progression to ESKD & early detection & treatment being the key.
GLTAH
PIQ Price at posting:
32.5¢ Sentiment: Buy Disclosure: Held
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