Alnylam updates its pitch for expanded Onpattro label with 18-month PhIII data
Alnylam Pharmaceuticals is so pleased with 18-month data from its Phase III trial investigating Onpattro as a treatment of ATTR cardiomyopathy that it submitted it as an amendment to its sNDA as analysts expect approval later this year with the data strengthening the application.
The trial, dubbed APOLLO-B, investigated the drug’s impact on the quality of life in patients with ATTR amyloidosis against a placebo. At the 12-month double-blinded (DB) assessment, the trial already hit its primary endpoint, which looked at the six-minute walk test in patients taking the drug against a placebo.
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