Alnylam Reinforces Patisiran Data In Stiff Heart Disorder Before Heading For FDA Approval

Alnylam Reinforces Patisiran Data In Stiff Heart Disorder Before Heading For FDA Approval
  • Alnylam Pharmaceuticals Inc ALNY announced results from exploratory endpoints and additional analyses from the APOLLO-B Phase 3 study of patisiran for transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy. 
  • The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced.
  • It also revealed more detail on a key miss, a composite secondary endpoint including all-cause mortality. The researchers noted the numbers trended toward a benefit for patisiran, with 10 all-cause deaths in the placebo group versus four in the treatment group.
  • Related: Alnylam Shares Detailed Patisiran Data From Rare Disease Study.
  • Alnylam also presented a handful of echocardiographic parameters or analyses on heart images produced by sound waves.
  • Patisiran showed a statistically significant benefit over placebo, including longitudinal strain (p=0.0324) and LV mass (p=0.0402). The p-value for LV end-diastolic volume came in slightly above 0.05, and no significant differences were seen in the mean or relative LV wall thickness and cardiac output.
  • The company said it plans on submitting a supplemental marketing application in ATTR amyloidosis with cardiomyopathy based on the APOLLO-B data by the end of the year.
  • Price Action: ALNY shares closed lower by 4.41% at $200.16 on Friday.

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