Alnylam Wins FDA Approval For Givlaari, Its Second RNAi Drug
Givosiran was approved by the US FDA for the treatment of acute hepatic porphyria, a rare generic blood disorder, nearly three months ahead of the action date.
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Founding CEO will remain involved with Alnylam’s scientific advisory board, while current president/COO Yvonne Greenstreet will move up to the chief executive’s office.
As with its first two approved RNAi therapies, Alnylam will negotiate value-based agreements with payers, but for Oxlumo, approved in pediatric patients, it will offer a patient need adjustment.
Building on data first reported last December, lumasiran appears on pace for approval by the December 2020 action date, but Dicerna still may show its drug is best-in-class.