The process could move forward quickly once Alnylam has submitted everything. The FDA granted fast-track status to patisiran in hereditary ATTR (hATTR) amyloidosis in 2013, meaning it may speed through the review process in six months once it is in front of the agency.
Alnylam, along with partner Sanofi Genzyme, is also working to win approval for patisiran in the rest of the world, starting with a filing in the European Union. The partners expect to get a filing to European regulators around the end of the year, with submissions in Japan, Brazil and other countries following in the first half of 2018.
