Alnylam Reports Submission of MAA to Brazilian Health Regulatory Agency for Onpattro (patisiran) to Treat Hereditary ATTR Amyloidosis with Polyneuropathy

Alnylam Initiates P-III ILLUMINATE-B Study of Lumasiran for Primary Hyperoxaluria Type 1 (PH1) in Pediatric Patients

Shots:

  • The MAA submission to ANVISA is based on P-III APOLLO study results assessing Onpattro in patients hATTR amyloidosis with polyneuropathy, evaluating its safety and efficacy and the results are also published in The New England Journal of Medicine in July 5, 2018
  • Alnylam’s Onpattro has also received ANIVSA’s Priority Review which is granted to innovative medicines treating rare diseases under this accelerated regulatory pathway with its expected decision in H1’20
  • Onpattro is an RNAi therapeutic that targets and silence TTR messenger RNA, further blocking the production of TTR protein before it is made targeting transthyretin (TTR), approved in Canada, Japan and the US FDA for polyneuropathy of hATTR amyloidosis in adults and in EU and Switzerland for hATTR amyloidosis in adults with Stage 1 or Stage 2 polyneuropathy

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