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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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.
Alnylam successfully completed a multi-pronged financing deal with the investment firm, which it will use to fund the development of more RNAi drugs.
Alnylam’s short-interfering RNA, Givlaari, has become the first treatment to be approved for preventing attacks of acute hepatic porphyria in the EU, and Alnylam wants to pursue a value-based agreement framework to accelerate patient and provider access.