REDEMPLO

REDEMPLO exhibited linear and time-invariant pharmacokinetics following subcutaneous injections within the dose range of 10 mg to 100 mg. The following pharmacokinetic parameters were observed in healthy adults after receiving a 25 mg dose of REDEMPLO.

AbsorptionPlozasiran peak plasma concentration (C max ) is 68.5 ng/mL. The median time to reach C max (T max ) is 6 hours.

DistributionPlozasiran is 78% protein bound in vitro at the clinically relevant plasma concentrations. Following subcutane...

The efficacy of REDEMPLO was demonstrated in a randomized, placebo-controlled, double-blind trial in adult patients with genetically confirmed or clinically diagnosed FCS maintained on a low-fat diet(≤20 grams fat per day) (Trial 1; NCT05089084). Patients were randomized to receive four total doses of REDEMPLO 25 mg (n=26) or matching placebo (n=25), injected subcutaneously once every 3 months over a 12-month treatment period The diagnosis of FCS was based on adults with a screening fasting TG ≥880 mg/dL refractory to lipid-lowering therapy, with a history of elevated triglycerides (in excess ...

Most common adverse reactions in REDEMPLO treated patients (incidence ≥10% of patients treated with REDEMPLO and >5% more frequently than with placebo) are hyperglycemia, headache, nausea, and injection site reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Arrowhead Pharmaceuticals Inc. at 1-844-REDEMPLO (1-844-733-3675), or https://arrowheadpharma.com/safetyreporting, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are co...

None. None. ( 4 )