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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The company expects to complete a rolling NDA submission for its second RNAi therapeutic in mid-2019, and sees an opportunity to target severe and more moderate patients with acute hepatic porphyria.
The commercial team is on board and ready to market the first FDA-approved RNAi therapeutic patisiran for hereditary transthyretin-mediated amyloidosis.