Long Wait Ahead For Novartis's Leqvio In US
German Launch In February, UK Maybe Q3
The timeline for a US resubmission of the closely watched PCSK9-targeting cholesterol treatment could be either Q2 or Q3 and approval will depend on whether the FDA needs to make a physical inspection of an Italian facility.
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The battle for PCSK9 inhibitor market share continues with Amgen’s Repatha outselling Praluent, but a now-ended patent dispute no longer threatens Regeneron’s ability to sell its product in the US.
The US FDA issued a complete response letter for inclisiran, delaying the launch of the RNAi-based PCSK9 inhibitor for high cholesterol.
Partnership includes provision for fast-tracked uptake of inclisiran in England, if NICE finds it cost effective.