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FDA Accepts NDA Submission for Acoramidis in ATTR-CM

The FDA's acceptance of the NDA for acoramidis in ATTR-CM was announced on February 05, 2024 and assigns a November 2024 PDUFA for the agent.

Ahmad masriBridgebio pharmaIsabelle lousadaDrug administrationAmyloidosis research consortiumBio pharma incorporatedNew drug applicationPrescription drug user fee actAmyloidosis researchTransthyretin amyloidAcoramidis ole data

Phase 3 Trial Confirms New Drug Safe, Effective for Fatal Heart Failure

Phase 3 Trial Confirms New Drug Safe, Effective for Fatal Heart Failure
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United statesIsabella graefDrug administrationStanford universityUniversity of south carolinaAmerican heart associationNew england journalPalo altoDaniel judgeMedical universitySouth carolinaTransthyretin amyloid

Tafamidis attenuates the decline of cardiac function in patients with transthyretin amyloid cardiomyopathy

1. Patients with transthyretin amyloid cardiomyopathy (ATTR-CM) managed with tafamidis showed decreased worsening in left ventricular (LV) systolic and diastolic function over 30 months compared to the placebo group. 2. Approximately half of the subjects enrolled in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) exhibited various levels of diminished left ventricular ejection fraction (LVEF),

Transthyretin cardiomyopathy clinical trialRating levelTafamidis treatmentTransthyretin amyloidAttr amyloidosisAttr cmTransthyretin amyloidosis attr

Antibody NI006 for treatment of transthyretin amyloid cardiomyopathy caused no serious adverse events

1. In this randomized controlled trial, the antibody NI006 for the treatment of transthyretin amyloid cardiomyopathy (ATTR) showed no associated drug-related serious adverse events. 2. The pharmacokinetic profile of NI006 was similar to an IgG antibody with no antidrug antibodies detected. Evidence Rating Level: 1 (Excellent) Study Rundown: ATTR can cause progressive and fatal amyloidosis that

York heart associationMinute medicine incRating levelTafamidis treatmentTransthyretin amyloidNew york heart associationAntibody ni006Chronic diseaseHeart transplantTransthyretin amyloid cardiomyopath

Acoramidis Reduces All-Cause, Cardiovascular Mortality at 30 Months in ATTR-CM

With BridgeBio Pharma Inc. expecting to complete a regulatory submission prior to the close of 2023, the 30-month results of ATTRibute-CM provide the most comprehensive overview yet of the benefit-risk profile for acoramidis in ATTR-CM.

Noord hollandJulian gillmoreCondonh bridgebioAmerican heart association julian gillmoreEuropean society of cardiologyEuropean society of cardiology congressCongress homeUniversity college london centre for amyloidosisBridgebio pharma incYork heart associationDrug administrationAmerican heart associationEuropean societyUniversity college london centreNew york heart associationNew drug application