Search Results for "amyloidosis"

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

This deck highlights data from the Phase 3 HELIOS-A trial of vutrisiran in patients with hATTR-PN.

Standard response letter on patisiran and pregnancy & lactation. This letter contains information on preclinical toxicology studies and the APOLLO, APOLLO-B, and HELIOS-A studies.

Standard response letter on patisiran and the APOLLO-B study, a study evaluating the efficacy and safety of patisiran in patients with ATTR with cardiomyopathy, including both hATTR and wtATTR.

Standard response letter on vutrisiran and vitamin A levels, including information on supplementation.

Standard response letter on the cross-reactivity between vutrisiran and patisiran.

Standard response letter on the preparation and administration of patisiran.

Standard response letter on patisiran and product stability. The letter includes information on the chemical, physical and photostability of the active substance, patisiran, and the diluted patisiran solution.

Standard response letter on patisiran and total dilution volume. This letter contains information on a stability study and the APOLLO, APOLLO-B, and Global OLE studies.

Standard response letter on patisiran and temperature excursions. The letter includes information on the impact of temperature excursions not lower than -4°C and up to 40°C on the stability of patisiran.

This handout provides an overview of ATTR manifestations and the diagnostic tools that can be used to assess their presentation.

Standard response letter on use of mRNA COVID-19 vaccines in patients receiving vutrisiran.

Standard response letter on patisiran and use in patients with heart transplant.

This deck highlights data from the phase 3 HELIOS-A trial, including exploratory cardiac endpoints and post-hoc analyses.

External title: Patisiran RWE in hATTR Amyloidosis External description: This slide deck highlights real-world evidence (RWE) data on the use of patisiran in patients with hATTR amyloidosis, including patients with polyneuropathy, cardiomyopathy, solid organ transplant, concomitant treatment or treatment switch.

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

Standard response letter on patisiran and compatibility with commonly used infusion components based on a compatibility and stability study.

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

Standard response letter on hospitalization and mortality data from patisiran clinical trials.

ATTR-CM HELIOS-B Data Summary deck provides a comprehensive overview of the HELIOS-B results. Also includes information on ATTR-CM and the MOA of RNAi therapeutics.

Standard response letter on patisiran and cardiac results in the Global OLE study, a study evaluating the long-term efficacy and safety of patisiran in patients with the polyneuropathy of hATTR.

Standard response letter on patisiran and management of extravasation. This medical information response contains information on extravasation prevention guidelines that were provided to patisiran clinical trial sites.

Standard response letter on the effect of patisiran on orthostatic hypotension in the APOLLO, Global OLE, and HELIOS-A studies.

Standard response letter on patisiran and premedications during the APOLLO, Global OLE, and APOLLO-B studies.

Standard response letter on infusion-related reactions observed in patisiran clinical trials and post-marketing.