ESC - 2012 Update: Effient, Vorapaxar and Tredaptive - Effient misses TRIOLOGY ACS - Competitive Risk Overhang on Brilinta Removed!; Vorapaxar - Turning back - Filing confirmed;
ESC - 2012 Update: Effient, Vorapaxar and Tredaptive - Effient misses TRIOLOGY ACS - Competitive Risk Overhang on Brilinta Removed!; Vorapaxar - Turning back - Filing confirmed; HPS-2 Thrive on Track to
A quick take on Key Presentations at ESC 2012
Effient Failure in TRILOGY ACS: We see Effient failure to demonstrate benefit in medically managed ACS patients in TRILOGY ACS study as a setback and will now restrict its positioning to young STEMI patients. This also removes competitive risk overhang on AZN’s Brilinta. Vorapaxar Filing based on subgroup analysis: Based on observed net clinical benefit, MRK intends to file Vorapaxar for approval in patients with prior history of MI and no stroke, but we see higher regulatory hurdles and if approved the commercial opportunity will be limited. Tredaptive- HPS-2 THRIVE Update: The study remains on track for completion by YE 2012 and we think this bodes well for a positive outcome. Increased rates of Myopathy are predominantly in Chinese patients and this is in line with previous findings. We do not see this as a potential safety concern.
A quick take on Key Presentations at ESC 2012
Effient Failure in TRILOGY ACS: We see Effient failure to demonstrate benefit in medically managed ACS patients in TRILOGY ACS study as a setback and will now restrict its positioning to young STEMI patients. This also removes competitive risk overhang on AZN’s Brilinta. Vorapaxar Filing based on subgroup analysis: Based on observed net clinical benefit, MRK intends to file Vorapaxar for approval in patients with prior history of MI and no stroke, but we see higher regulatory hurdles and if approved the commercial opportunity will be limited. Tredaptive- HPS-2 THRIVE Update: The study remains on track for completion by YE 2012 and we think this bodes well for a positive outcome. Increased rates of Myopathy are predominantly in Chinese patients and this is in line with previous findings. We do not see this as a potential safety concern.
