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.