FDA Approve New Drug for ATTR-CM - rarediseaseadvisor.com
2 days ago · ATTR-CM is a progressive disease characterized by the accumulation of misfolded TTR proteins in the heart muscle and other parts of the body causing damage. ... (≥90%), approved by FDA to reduce cardiovascular death and cardiovascular-related hospitalization in ATTR-CM patients. News release. BridgeBio. November 22, 2024. Efficacy and safety ...
FDA approves drug for heart disorder caused by transthyretin …
2 days ago · There are two types of ATTR-CM, hereditary ATTR-CM (hATTR-CM) and wild-type ATTR-CM (wATTR-CM). In hATTR-CM, which can run in families, there’s a variant in the transthyretin gene, which results ...
Attruby™ (acoramidis), a Near Complete TTR Stabilizer (≥90%), …
News; Attruby™ (acoramidis), a Near Complete TTR Stabilizer (≥90%), approved by FDA to Reduce Cardiovascular Death and Cardiovascular-related Hospitalization in ATTR-CM Patients ... The FDA approval is based on positive results seen in the ATTRibute-CM Phase 3 study, where Attruby significantly reduced death and cardiovascular-related ...
FDA Approves Attruby - Drugs.com
The ATTRibute-CM Phase 3 study enrolled 632 participants with symptomatic ATTR-CM, associated with either wild-type or variant TTR. Participants were randomized 2:1 to receive Attruby or placebo for 30 months. ... More news resources. FDA Medwatch Drug Alerts; Daily MedNews; News for Health Professionals; New Drug Approvals; New Drug ...
FDA Update: Acoramidis Approved to Reduce CV Death, …
1 day ago · The approval of the near-complete TTR stabilizer comes following positive results from the ATTRibute-CM Phase 3 study, where acoramidis was compared with placebo in patients with symptomatic ATTR-CM. The trial’s primary endpoint – a four-component composite endpoint of all-cause mortality, cardiovascular-related hospitalization, NT-proBNP ...
FDA Approves First ‘Near-Complete’ Stabilizer to Treat ATTR ...
1 day ago · The 632-patient ATTRibute-CM study found that those who took oral acoramidis 800 mg twice daily had improvements in the hierarchical primary composite endpoint of all-cause mortality, cardiovascular hospitalizations, change from baseline in NT-proBNP, and change from baseline in 6-minute walk distance at 30 months compared with those randomized ...
FDA Approves Acoramidis for ATTR-CM - drugtopics.com
2 days ago · According to a news release from manufacturer BridgeBio, acoramidis “was designed to mimic a naturally occurring ‘rescue mutation’ of the TTR gene”—T119M—targeting destabilization of the native TTR tetramer, the root cause of ATTR-CM. Approval was based on results of the double-blind, phase 3 ATTRibute-CM clinical trial (NCT03860935).
FDA Approves New Drug for Life-Threatening Heart Condition
2 days ago · The FDA has approved Attruby, a new oral treatment that helps reduce heart-related deaths and hospital visits among adults with transthyretin amyloid cardiomyopathy, or ATTR-CM. ATTR-CM is a rare ...
Attruby™ (acoramidis), a Near Complete TTR Stabilizer (≥90%), …
4 days ago · Attruby was designed to mimic a naturally occurring "rescue mutation” of the TTR gene (T119M) that targets the root cause of ATTR-CM, destabilization of the native TTR tetramer.
FDA approves new treatments for heart disease caused by a …
On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by...
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