Search Results for "diagnosis"

Standard response letter on renal effects observed with the use of givosiran.

Standard response letter on givosiran and hypersensitivity, including anaphylactic reactions, observed.

This infographic about AHP describes the types of the disease, including AIP, pathophysiology, clinical presentation of acute and chronic symptoms, epidemiology, and diagnosis

Standard response letter on CYP enzyme drug-drug interactions with givosiran.

Standard response letter on givosiran and injection site reactions during the phase 1, phase 1/2 open-label extension, and phase 3 ENVISION studies.

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 the APOLLO-B OLE study of patisiran.

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.

This infographic details the lumasiran clinical program (including ILLUMINATE) which investigates the treatment of primary hyperoxaluria type 1 with lumasiran.

Standard response letter on zilebesiran and the phase 2 studies: KARDIA-1, KARDIA-2, and KARDIA-3.

Standard response letter on givosiran and elevations in blood homocysteine.

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

Standard response letter on the efficacy of vutrisiran in patients with and without atrial fibrillation or flutter.

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 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 patisiran and use in patients with heart transplant.

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

The porphyria burden assessment (PBA) is a digitally accessible patient questionnaire intended to capture patients’ lived experiences of acute hepatic porphyria (AHP), focused on the chronic symptom burden associated with the condition and the impact of AHP on daily life

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

Standard response letter on the efficacy and safety of vutrisiran and patisiran, summarizing data from the HELIOS-A study and the APOLLO study.

Standard response letter summarizing the results of a post-hoc analysis of the HELIOS-A study, conducted to evaluate the impact of baseline polyneuropathy severity, as measured by NIS, on response to vutrisiran treatment.

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

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

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

Standard response letter on vutrisiran and concomitant use with tafamidis.