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Re: DewDiligence post# 213276

Monday, 11/13/2017 2:03:39 PM

Monday, November 13, 2017 2:03:39 PM

Post# of 257575
NVS presents new subset data from CANTOS study of Ilaris in CVD:

https://globenewswire.com/news-release/2017/11/13/1185350/0/en/Novartis-canakinumab-ACZ885-reduced-cardiovascular-risk-by-25-in-subgroup-of-CANTOS-Phase-III-trial-participants.html

The pre-planned secondary analysis of an exploratory endpoint showed that people with a prior heart attack who achieved hsCRP levels below 2mg/L at three months after the first dose of canakinumab had a 25% reduction in major adverse cardiovascular events (MACE) versus placebo (HRadj=0.75, 95% CI 0.66-0.85, p<0.0001). These patients also had a significant reduction of 31% in the rate of cardiovascular (CV) death (HRadj=0.69, 95% CI 0.56-0.85, p=0.0004) and all-cause death (HRadj=0.69, 95% CI 0.58-0.81, p<0.0001).

There was no significant reduction in these endpoints observed among those treated with canakinumab who achieved hsCRP levels equal to or above 2mg/L.

This analysis indicates that on-treatment hsCRP testing may offer a quick and reliable way to identify the patients most likely to achieve the greatest benefits from long-term canakinumab treatment. It also demonstrates that treating inflammation in addition to lowering cholesterol may significantly reduce the risk of recurrent CV events.

NVS may lean on these subset data in seeking an expanded label for Ilaris that makes sense from a reimbursement standpoint.

This PR was issued in conjunction with NVS' Investor Day presentation today (see next post).

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