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AHP Diagnosis

This material is a short summary of HELIOS-B primary medical and scientific publications (including peer-reviewed medical journal articles and scientific conference presentations)

Standard response letter on vutrisiran and the open-label extension period of the HELIOS-B study, a phase 3 study evaluating the efficacy and safety of vutrisiran in patients with the cardiomyopathy of ATTR, including both hATTR and wtATTR.

Standard response letter on exploratory cardiac biomarker analyses in HELIOS-B.

This slide deck highlights the Phase 3 trial design for HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy.

Standard response letter on givosiran and the Phase 1/2 open-label extension study, an extension of the Phase 1 clinical study to evaluate the long term safety and tolerability of givosiran in patients with AIP for up to 48 months.

Standard response letter on vutrisiran and use in patients with hepatic impairment.

Standard response letter on givosiran and its use in pregnant or lactating patients.

Standard response letter on the lumasiran phase 3 clinical study ILLUMINATE-A, a study evaluating the efficacy and safety of lumasiran in adults and children who are 6 years of age or older with PH1.

Standard response letter on vutrisiran and concomitant use with tafamidis.

Standard response letter on lumasiran and protocol for dosing in pediatric patients who experience weight increases.

Standard response letter on lumasiran phase 3 clinical study ILLUMINATE-C, a study evaluating the efficacy and safety of lumasiran in infants to adult patients with PH1 and advanced kidney disease.

Standard response letter on givosiran and the 36-month results of the ENVISION study, a phase 3 study evaluating the efficacy and safety of givosiran in patients with a documented diagnosis of AHP.

Standard response letter on vutrisiran and safety information from the HELIOS-B study.

Standard response letter on lumasiran and kidney-related measures such as eGFR, kidney stone event rates, and nephrocalcinosis across clinical trials.

An infographic depicting a post-hoc analysis of the ENVISION phase 3 study to understand the long-term clinical outcomes of patients who were not attack free after 6-months of givosiran treatment.

Standard response letter on vutrisiran and exploratory echocardiographic assessments of cardiac structure and function in HELIOS-B.

Standard response letter on switching from TTR stabilizers (tafamidis, acoramidis, or diflunisal) to vutrisiran.

Standard response letter on lumasiran and the dosing administration window in the ILLUMINATE-A, ILLUMINATE-B, and ILLUMINATE-C studies.

Standard response letter on the APOLLO-B OLE study of patisiran.

Standard response letter on the dosing schedules of vutrisiran used in the HELIOS-A and HELIOS-B studies.

Standard response letter on the use of vutrisiran in patients with AL amyloidosis or leptomeningeal amyloidosis.

Standard response letter on vutrisiran and anti-drug antibodies. This letter contains information on the percentage of patients in vutrisiran clinical studies who tested positive for anti-drug antibodies.

Standard response letter on vutrisiran and post-dose monitoring in the HELIOS-A and HELIOS-B studies.

Standard response letter on transitioning from an antisense oligonucleotide to vutrisiran.