Alnylam Ramps Up Commercial Planning For Givosiran Based On Phase III Data
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.
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Keeping Track Of Approvals: Two Novel Drugs (Givlaari And Xcopri), A Project Orbis Collaboration (Calquence) And Another Humira Biosimilar
The latest news on US FDA drug approvals.
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.