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Alnylam Reports P-III (APOLLO-B) Trial Results of Patisiran for the Treatment of ATTR Amyloidosis with Cardiomyopathy

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Alnylam Reports P-III (APOLLO-B) Trial Results of Patisiran for the Treatment of ATTR Amyloidosis with Cardiomyopathy

Alnylam Reports P-III (APOLLO-B) Trial Results of Patisiran for the Treatment of ATTR Amyloidosis with Cardiomyopathy

Shots:

  • The P-III (APOLLO-B) trial evaluate patisiran (0.3mg/kg) in a ratio (1:1) in 360 patients with ATTR amyloidosis (hereditary or wild-type) with cardiomyopathy at 69 sites in 21 countries
  • The trial met its 1EPs & 2EPs i.e., change from baseline in 6-MWT @12mos. & health-related QoL & also showed a composite of all-cause mortality, frequency of CV events & change from baseline in 6-MWT; frequency of all-cause hospitalizations & urgent HF visits in patients not on tafamidis at baseline & overall study population along with encouraging safety & tolerability profile
  • The exploratory endpoints incl. cardiac biomarkers & multiple imaging tools to characterize the burden of cardiac involvement. The company plan to submit the sNDA of patisiran with the US FDA in late 2022

Ref: Alnylam | Image: Alnylam

 

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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