EU: PRIME Success For Givlaari At CHMP
EMA Panel Recommends Alnylam’s Givosiran For Approval
Interaction with the European Medicines Agency on Givlaari helped Alnylam prepare a more robust application package to demonstrate the medicine’s benefits and risks.
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EU marketing applications from Vertex and Roche have reverted to standard review timelines at the European Medicines Agency. The outcomes of three fast-track requests that companies have made for their planned filings are still unknown.
A plethora of new drugs moved closer to the EU market this week after the European Medicines Agency recommended that they should be approved.
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.