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.
The company will launch Givlaari with a novel prevalence-based adjustment feature for payers, which will trigger higher rebates if the number of diagnosed patients is higher than expected.
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.