From Texbraska,

"Bottom line: is this drug ready to help people that need it (and produce profits)? Is it in need of more studies (from a wealthy BP)?  The potential health and monetary beneficiaries would all love to know!"

I am not the person to answer this question as I have no particular knowledge of the regulatory process.  One of the doctors on the site (DebKCardsPA) suggested:

"Concise snapshot of our likely starting market; diabetics with higher grade CKD; at high risk of CVD events."

CKD patients were the hardest hit by MACE in this trial and did seem to gain the most benefit in terms of MACE reduction from apabetalone - this seems likely the target group for the breakthrough drug application, but I don't know the timeline for this even if the application is successful.  The sample size of CKD patients is pretty small (263 with only 110 on apabetalone) but RVX may have some biomarker data to back up the indication of benefit in the group.  Did eFGR improve in this group?  alkaline phosphatase levels go down?  If so these data could provide pretty strong corroboration of benefit. Particularly exciting would be good cognitive function results for this group, which may be on the horizon.

The FDA knows how strong the need for CKD drugs is - but they need to be convinced that apabetalone will meet that need.  There may be others on the board who can judge whether more data for CKD patients will be needed to support a breakthrough drug classification, and what the timelines will be.

Jupe