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key point:
- An analysis of the pre-designated high-risk group in the DREAM-HF Phase 3 trial of Rexlemestrocel-L in patients with chronic heart failure and low ejection fraction (HFrEF) showed that the major adverse cardiovascular events in cardiovascular death or cardiovascular death ( MACE) has the greatest benefit, or irreversible incidence (non-fatal heart attack or stroke) in patients with diabetes and/or myocardial ischemia (72% of the total treated population)
- Despite receiving the best standard of care, the target population is still at high risk of death and irreversible morbidity due to microvascular and macrovascular diseases 1
- Rexlemestrocel-L is added to the standard of best care treatment, reducing the 3-point MACE compound of cardiovascular death or heart attack or stroke in all patients with diabetes and/or ischemia HFrEF by 37%, and will suffer from systemic inflammation The 3-point MACE compound of cardiovascular death, heart attack, or stroke in HFrEF patients was reduced by 54% (increased baseline hs-CRP)
- The U.S. Food and Drug Administration (FDA) has previously accepted 12-14% of the 3-point MACE reduction to approve a variety of drugs in the pharmaceutical industry to reduce the cardiovascular risk of diabetic patients 2,3
- The FDA confirms that reducing cardiovascular mortality or irreversible morbidity (non-fatal heart attack or stroke) is an acceptable clinically meaningful endpoint for determining the therapeutic benefit of rexlemestrocel-L in patients with HFrEF
- Mesoblast formally submitted its new analysis of the results of high-risk HFrEF patients with diabetes and/or myocardial ischemia to the FDA to agree on a potential route for approval.
New York, December 5, 2021 (Global News Agency) – Mesoblast Limited (NASDAQ:Middleware, ASX:MSB)) is a global leader in allogeneic cellular drugs for inflammatory diseases. Today, it provides a new analysis of the landmark DREAM-HF Phase 3 trial, showing that the greatest therapeutic benefit of rexlemestrocel-L is diabetes and Patients with ischemic HFrEF are at high risk of cardiovascular death, heart attack or stroke.
In the recent Mesoblast guidelines, the FDA confirmed that the reduction in the incidence of cardiovascular mortality or irreversible morbidity (non-fatal heart attack or stroke) is a clinically significant acceptable endpoint for patients with chronic HFrEF, and encouraged Mesoblast to determine the highest risk The possibility of a beneficial response to rexlemestrocel-L intervention in the DREAM-HF phase 3 trial.
According to the guidelines, Mesoblast performed an additional analysis of the MACE results of the pre-designated high-risk patient group in the landmark DREAM-HF trial. The results were presented by CEO Dr. Silviu Itescu at the 18th Global Cardiovascular Announced at the Washington DC Forum (CVCT) in the clinical trial.
Data Display:
- Although a single dose of rexlemestrocel-L based on the highest standard of care therapy reduced the composite 3-point MACE of all 537 patients by 33% (p=0.02) during an average follow-up of 30 months, it was a cross-pretreatment score. Hierarchical analysis of specific high-risk subgroups showed the greatest benefit in patients with diabetes and/or myocardial ischemia (hazard ratio 0.63, p=0.019)
- Among the control patients (n = 276) with HFrEF, all of these patients received the maximum available standard…
The full story can be found on Benzinga.com
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