19 October 2018 - The U.S. FDA has rejected Novartis’s bid to repurpose a drug now approved for rare inflammatory diseases to be used in a group of heart attack survivors, the Swiss drug maker said on Thursday.
The company received an FDA letter turning down its bid to make canakinumab a targeted therapy for those cardiovascular patients who in tests had quickly responded to treatment, as levels of a protein in their blood associated with inflammation and heart disease quickly plunged.
Canakinumab made headlines in 2017, when data from a six-year study of about 10,000 patients proved that fighting inflammation with the drug - not merely lowering cholesterol - helped heart attack victims avoid future attacks or death.