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US clearance stalled after the US FDA questioned "unresolved facility inspection-related conditions" at the Italian plant of Novartis supplier Corden Pharma.
The analysis evaluated the efficacy and tolerability of inclisiran on top of a maximally tolerated dose of statins, in two studies of more than 2,300 patients (of which 1,164 were on inclisiran).
Alnylam is the first drugmaker to win US approval for a treatment using the Nobel prize-winning RNA interference (RNAi) technology and is currently developing other RNAi drugs to treat a range of conditions, including rare bleeding disorders.