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Amvuttra’s Approval | Generic Rivaroxaban March 24, 2025
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Together with
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“If the goal is truly evidence-based practice, then the appropriate response is not to defend integrative medicine as a field, but rather to subject all interventions—regardless of their origins—to the same uncompromising scrutiny.”
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Danielle Belardo, MD
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Cardiology Pharmaceuticals
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It’s not surprising that Alnylam’s Amvuttra (vutrisiran) received FDA approval for ATTR-CM last week, but what shocked many was Alnylam’s choice to price the drug at nearly half a million dollars per year in a segment where its incumbent competitors cost half as much.
- Amvuttra is now the third FDA-approved therapy for ATTR-CM, following Pfizer’s Vyndaqel and BridgeBio’s Attruby/Beyonttra.
- The HELIOS-B study found Amvuttra reduces all-cause mortality and cardiovascular events in ATTR-CM patients compared to placebo, supporting the FDA’s approval.
- Amvuttra was already approved for transthyretin amyloid polyneuropathy (ATTR-PN).
Alnylam claims Amvuttra’s eyewatering price stems from the drug’s “compelling and highly differentiated value for patients and physicians, as well as payers.”
- Part of this pricing argument is the slight difference in how Amvuttra works, since it’s the first ATTR-CM drug that silences the disease-causing protein rather than stabilizing it.
- Alnylam also believes patients are more likely to stick to quarterly injections of Amvuttra than remembering to take their pills every day.
- Even so, Amvuttra costs $476k annually, far surpassing the list prices for Vyndaqel ($250k) and Attruby ($244k), which have already seen scrutiny for their high costs
Amvuttra’s pricing might be part of a bigger strategy though since it’s administered through Medicare Part B (physician-administered medicines) instead of via Part D like Vyndaqel and Attruby.
- About 75% to 80% of eligible ATTR-CM patients are covered by Medicare, so doctors may be incentivized to prescribe more expensive Part B medicines.
Beyond Amvuttra’s financial strategy and its mortality and CV event improvements in the HELIOS-B study, a recent JACC study suggests the drug could help maintain or even improve functional capacity, health status, and QOL in patients with ATTR-CM.
- Compared to placebo, more patients on Amvuttra maintained or improved 6-MWT distance (>7 m [49.6% vs 33.2%], >15 m [55.5% vs 38.6%], and >35 m [68.4% vs 51.6%]).
- More patients on Amvuttra also maintained or improved their KCCQ-OS scores (>5 points [63.5% vs 46.6%], >10 points [74.6% vs 60.7%]).
The Takeaway
Amvuttra’s FDA approval now means we have a third drug for ATTR-CM that works differently than the current competitors. Whether that difference will justify Alnylam’s pricing strategy remains to be seen.
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Automating and Simplifying CMR Imaging
Watch Vista.ai’s demo on how their intelligent software automates and simplifies image acquisition so all technologists can perform a CMR scan with quality, consistency, and efficiency, increasing throughput and improving patient access.
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Offer Hope Not Just Inotrope to Your Patients with Advanced Heart Failure
Left ventricular assist devices (LVADs) have received Level 1A Recommendation from the AHA/ACC/HFSA guidelines.
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Redefining Percutaneous Coronary Intervention
Learn about the AGENT™ Drug-Coated Balloon from Boston Scientific and how this technology is expanding the treatment options for patients with in-stent restenosis in the U.S. Rx only. (Sponsored by Boston Scientific)
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- Generic Rivaroxaban On the Way! The FDA approved the first generic versions of rivaroxaban, but despite the increased availability of the direct-acting oral anticoagulant, the immediate impact may be limited. The newly approved generics are equivalent to a 2.5 mg dose of rivaroxaban, which can be used to reduce the risk of MACE in adults with CAD and PAD. However, this dose is not intended to be used for the treatment and prevention of venous thromboembolism, where DOACs like rivaroxaban have largely replaced warfarin.
- Steps + Heart Rate for CVD Risk: Tracking heart health could be as simple as wearing a smartwatch and combining how much you walk with your heart rate. As part of an ACC.25 study, researchers developed a new metric called daily heart rate per step (DHRPS), finding that patients with elevated DHRPS (top 25%) experienced 2x higher T2D risk, 1.7x higher HF risk, 1.6x higher elevated BP risk, and 1.4x higher coronary atherosclerosis risk compared to people with lower DHRPS.
- Lowering APOC3 & LDL-C? New genetic research suggests combining APOC3–targeting drugs with LDL-C–lowering drugs could be a new way to reduce coronary heart disease risk. A UK Biobank study examined genetic data from over 400k patients and found that combined exposure to genetically lower APOC3 and PCSK9 levels led to a 10% lower risk of CHD. While the associations are not due to therapeutics, researchers suggest the findings warrant full scale studies for a combined APOC3/LDL-C regimen.
- New Procedure for LAA Thrombi: Persistent left atrial appendage thrombi can be difficult to manage when high-dose anticoagulation isn’t an option, but a recent JAMA study suggests mechanical aspiration could be the answer. Researchers studied nine patients with LAA thrombus ineligible for anticoagulation and found that combining cerebral protection, percutaneous mechanical vacuum thrombectomy, and mechanical LAA closure led to successful treatment in all nine patients with no complications or adverse effects.
- Cardiac Dimensions’ Series E: Cardiac Dimensions announced the close of its $53M Series E financing round for funding the development of its minimally invasive HF and functional MR treatments. The fresh funds are earmarked for the global commercial expansion of Cardiac Dimensions’ Carillon therapy that uses a catheter-based procedure to restore natural mitral valve function without damaging the mitral valve leaflets. The Carillon therapy works for early-stage FMR as a front-line treatment option since it doesn’t prevent future MR therapies.
- Myant’s AI Cardio Assessment: Myant launched its Myant Care360 service for making specialist cardiac care more accessible while improving AFib detection. The Myant Care360 platform works as a direct-to-patient and physician cardiac assessment service that offers 14-day or longer AI- powered cardiac assessments, delivered to the patient’s home within 48hrs. As part of the platform, Myant uses advanced sensors for continuous ECG analysis that detects AFib and provides personalized heart health insights as well as direct-to-ablation referrals when needed.
- T45’s Funding Success: Medtech incubator, T45 Labs announced the successful close of its $25M T45 Fund I to help advance the milestones of its portfolio of cardiovascular medical device companies like Advanced NanoTherapies, Vahaticor, NuevoSono, and Recava. The portfolio of companies specialize in drug-coated balloons, coronary microvascular dysfunction, intra-vascular imaging, and congestive heart failure.
- Marijuana’s CVD Risks: In a shock to no one, a recent study found that people under 50 who use marijuana could be at greater risk of more adverse cardiovascular events compared with nonusers. The observational study analyzed data from 4.6M people and found that marijuana users faced significantly higher risks of MI (RR: 6.18) and ischemic stroke (4.33) compared to nonusers over a 36 month follow-up.
- Bracco Updates HeartSee: Bracco Diagnostics upgraded its HeartSee software for myocardial blood flow quantification via cardiac PET imaging. These updates launch with v4.0 of the software and include a new feature called relative stress flow that assesses subendocardial border zones in areas with mildly reduced coronary flow capacity. The new updates also launch on Windows 10/11, streamlining integration in hospital and clinic settings.
- Finerenone Reduces New AFF: It seems like every month a new finerenone benefit is being discovered, and a recent JACC study has added AFib to the list. As part of a combined prespecified analysis of FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF, researchers examined 14.5k patients, uncovering that those who received finerenone had a 17% lower risk of developing new AFib compared to placebo during the study’s 2.9 year follow-up.
- AI of BAC Predicts Cardiac Events, Mortality: In research at next week’s ACC 2025 meeting, a homegrown AI algorithm calculated breast arterial calcification on screening mammograms. In a study of 56.6k women, women younger than 80 with the highest BAC levels (>40 mm2) had worse five-year rates of acute myocardial infarction (91% vs. 97%), stroke (84% vs. 93%), heart failure (85% vs. 96%) and death (86% vs. 95%) compared to those with the lowest BAC levels (>10 mm2).
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Making Cardiovascular Data Work for You
Today, cloud-native analytics can automate data acquisition and synthesize complex data. Discover what Optum’s technology can do to facilitate future advancements in cardiovascular data and analytics.
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HeartFlow Evidence
With 500+ peer-reviewed publications, HeartFlow has shown its commitment to clinical research, and validated its potential to transform the diagnosis and management of coronary artery disease worldwide.
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Cardiology AI: From Research to Clinical Practice
Explore how AI algorithms are reshaping cardiology with insights from Tempus’ recent webinar, featuring Dr. David Ouyang of UCLA and Cedars-Sinai, alongside Tempus’ Dr. John Pfeifer and Dr. Brandon Fornwalt. This expert panel dives into how AI can bridge diagnostic gaps, enhance patient outcomes, and streamline workflows for conditions like AFib and pulmonary hypertension. Read the full recap to glimpse the future of AI-driven cardiology.
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- PIA Medical Processes It All: Need an analysis like calcium scoring, strain or even FFR? PIA Medical began as a Core Lab and can handle creative cardiac research and clinical trials along with the full breadth of clinical analyses available today.
- A New Era of Precision and Efficiency: Ready to enhance your cardiovascular imaging precision and efficiency? See how Circle Cardiovascular Imaging’s new cvi42 6.1 platform is bringing CT and MR imaging under a single platform.
- A Universal View of Your Patient: Think you’re getting the most out of your viewer? See how GE HealthCare’s Centricity Cardio Enterprise Universal Viewer allows you to quickly review exams, access and compare prior studies, and perform measurements in this 60-second video.
- Visit Us2.ai at ACC 2025: Us2.ai will be at ACC 2025 March 29-31. Join them for live scanning and experience the cutting-edge AI technology that’s redefining echocardiography. Find them in the booths of Viz.ai #11055 or Fujifilm #13001.
- Partnerships That Produce Results: Find out how Monebo can help you develop algorithms that meet your specific ECG analysis needs using its Kinetic Family of ECG Algorithms that scale for use in devices utilizing small microcontrollers or DSP’s, all the way up to PC or server-based platforms.
- Explore Vitrea Advanced Visualization: Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow
- A Better Way to Coordinate Post-Stroke Care: Think your EHR messaging system might be holding back your post-stroke care? See how UC San Diego Medical Center streamlined its neuro and EP teams’ post-stroke workflow with Viz Connect, and the impact it had on cardiac monitor placements in inpatient and outpatient settings.
- Experience the future of learning: Medtronic Academy 2.0 is here! Unlock your ultimate destination for structural heart medical education with the newly redesigned Medtronic Academy 2.0. Gain access to expert-led courses, webinars, and a wealth of resources to stay ahead in cardiovascular care. Visit now!
- Cleerly Transforming Cardiovascular Event Prevention: There’s been plenty of studies evaluating healthcare AI accuracy, but does AI improve patient care? Check out this Cardiac Wire show with Udo Hoffmann, MD, MPH and learn how Cleerly’s new TRANSFORM trial could prove that AI-guided cardiovascular care reduces heart attacks.
- Streamline Your Cardiology Imaging Workflows: See how cardiologists and their teams can streamline imaging workflows to make their cardiovascular service line more efficient, cost-effective, and patient-centered, using Merge’s cardiology solutions.
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