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Bridgebio seeks Japan approval of acoramidis for rare heart disease

Armed with strong phase III safety data in Japanese patients, Palo Alto, Calif.-based Bridgebio Pharma Inc. is planning to file for Japan approval of its investigational drug acoramidis for a rare heart disorder. ....

Pharma Inc , Palo Alto , Bridgebio Pharma , Bridgebio Pharma Inc , Asia Pacific , Attr Cm , Transthyretin Meditated Amyloid Cardiomyopathy , Pfizer Inc , Attribute Cm , Phase Iii , Safety Data , Alnylam Pharmaceuticals Inc , Ionis Pharmaceuticals Inc , Astrazeneca Plc , Intellia Therapeutics Inc , Ntla 2001 , Transthyretin Amyloid Cardiomyopathy , Bioworld Asia ,

Patisiran prevents functional decline in patients with cardiac amyloidosis

1. In this randomized controlled trial, patisiran demonstrated a reduction in functional capacity decline transthyretin amyloidosis (ATTR amyloidosis) with a cardiac component as compared to placebo. 2. Compared to placebo, patisiran demonstrated a higher rate of infusion-related reactions, arthralgias, and muscle spasms. Evidence Rating Level: 1 (Excellent) Study Rundown: ATTR amyloidosis is a serious condition ....

Minute Medicine Inc , Rating Level , Kansas City Cardiomyopathy Questionnaire , Overall Summary , Amyloid Fibrils , Attr Amyloidosis , Cardiac Amyloidosis , Chronic Disease , Transthyretin Amyloidosis , Transthyretin Amyloidosis Attr ,

#VisualAbstract: Patisiran Treatment in Patients with Transthyretin Cardiac Amyloidosis

Click here to read this study in NEJM. ©2023 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute ....

Minute Medicine Inc , Transthyretin Amyloidosis ,

FDA Issues CRL for Patisiran in Treatment of ATTR Cardiomyopathy

Announced on October 9, the decision to issue a CRL is based on the FDA's belief the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis had not been established. ....

United States , Kunzmannk Patisiran , Campbellp Patisiran , Ahmad Masri , Christopher Oconnor , Yvonne Greenstreet , Alnylam Pharmaceuticals , Investor Relations Alnylam Pharmaceuticals Inc , Oregon Health , Renal Drugs Advisory Committee , Vascular Institute , Hypertrophic Cardiomyopathy Center , Drug Administration , Sciences University , Complete Response Letter , Chief Executive Officer , Annual Congress , Heart Failure Association , European Society , New Drug Application , Christophero Connor , Inova Heart , Supplemental New Drug Application , Patisiran Onpattro , Attr Cm , Patisiran In Cardiomyopathy ,

Expert Perspective: FDA CRDAC Vote on Patisiran for ATTR-CM, with Ahmad Masri, MD, MS

Ahmad Masri, MD, MS, provides his perspective on the APOLLO-B data and reacts to the FDA CRDAC 9 to 3 vote in favor of the benefit-risk profile for patisiran in ATTR-CM. ....

United States , Javed Butler , Ahmad Masri , Baylor Scott , Science University Ahmad Masri , Science University , Renal Drugs Advisory Committee , Drug Administration Cardiovascular , Advisory Committee , Division Of Cardiovascular Medicine , Oregon Health , Hypertrophic Cardiomyopathy Center At Oregon Health , White Research Institute , Drug User Fee Act Target Action , Drug Administration , Kansas City Cardiomyopathy Questionnaire , White Research , Cardiovascular Medicine , Hypertrophic Cardiomyopathy Center , Fda Crdac , Attr Cm ,