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

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

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  • 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

Click here to­ read full press release/ article | Ref: PRNewsWire | Image: Twitter


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