Biotech Values

[DewDiligence]

NVS receives CRL for Ilaris BLA based on CANTOS study:

https://endpts.com/fda-slaps-down-novartis-blockbuster-pitch-for-canakinumab-so-what-went-wrong

Based on the correspondence from the FDA, the CANTOS data would not support labeling for the use of canakinumab as a targeted therapy for those patients with cardiovascular disease who achieved a reduction of hsCRP below the 2 mg/L target. At this time, we are evaluating the feedback provided and plans further discussions with the FDA.

So, Ilaris remains a niche drug (for now), and NVS does not have worry about the “pricing problem” an approval in a mass-market indication would have caused.

See #msg-134168467 for related info.