The American College of Cardiology (ACC) 67th Scientific Session was held in Orlando, FL from 10-12 March 2018.
The highlight of this year's conference was results from Praluent's (REGN, SNY) ODYSSEY cardiovascular outcomes trial (CVOT), which were interesting to compare to Repatha's (AMGN, Astellas) FOURIER results presented at last year's conference. While the benefit on the primary endpoint was similarly modest, unlike FOURIER, there were signs of a mortality benefit, and patients with higher baseline LDL-C levels showed relatively strong results. However, the biggest news was that, in exchange for reduced barriers from US payers, the sponsors plan to negotiate net price down into a range based on a cost-effectiveness analysis for high-risk patients concurrently released by the ICER organization. We discuss the implications of these developments, including highlights from interviews with payers and comments from KOLs.
There was also updated data from AndexXa's single-arm Phase III trial ANNEXA-4, but little more information to help gauge whether the FDA will require a randomized controlled trial pre- or post-approval.
On the device front, results from VEST, the first randomized trial of Zoll's LifeVest wearable cardioverter defibrillator for prevention of sudden cardiac death, were mixed, triggering a great deal of discussion among cardiologists. Positive long-term results were also presented for HeartMate 3 (ABT), bolstering the left ventricular assist device (LVAD) in its competition against Medtronic's HeartWare HVAD.
This report also has information on Repatha and hsCRP, analyses from Ilaris's (NVS) CANTOS study, Brilinta (AZN, MDCO) after fibrinolysis, preliminary data from BC007 (Berlin Cures), an aptamer that targets autoantibodies being developed for dilated cardiomyopathy, and CoreValve (MDT) long-term data compared to surgical aortic valve replacement and from the US Pivotal Extreme Risk Study.
Key Topics Covered:
Praluent (alirocumab; REGN, SNY) - Approved
HIGHLIGHTS FROM PAYER INTERVIEWS ON PCSK9 INHIBITORS
Evacetrapib (LLY) - Suspended
Dalcetrapib (DalCor Pharmaceuticals, RHHBY, Japan Tobacco) - Phase III
AKCEA-APOCIII-LRx (AKCA, IONS, NVS) - Phase II
AndexXa (andexanet alfa; PTLA) -Phase III
Aironite (sodium nitrite inhalation solution; SVRA) - Suspended
Mavacamten (MYOK, SNY) - Phase II
Acute Coronary Syndrome
Peripheral Arterial Disease
JVS-100 (Juventas) - Phase II
CV Safety in Gout
Uloric (febuxostat; Takeda, ABBV, Teijin, Ipsen, Menarini, Astellas) - Approved
LifeVest Wearable Cardioverter Defibrillator (ZOLL Medical) - Approved
Left Ventricular Assist Devices (LVAD)
HeartMate 3 (ABT) - Approved
Patent Foramen Ovale (PFO) Closures
Amplatzer PFO Occluder (ABT) - Approved
Transcatheter Aortic Valve Replacement (TAVR/TAVI)
CoreValve (MDT) - Approved
For more information about this report visit https://www.researchandmarkets.com/research/qf3l8p/2018_post?w=4