Novartis' Inclisiran Grounded In The US By FDA Inspection Restrictions
The US FDA issued a complete response letter for inclisiran, delaying the launch of the RNAi-based PCSK9 inhibitor for high cholesterol.
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MK-0616 – administered orally – reduced LDL cholesterol in patients in two early clinical trials presented at the American Heart Association Scientific Sessions.
Two years into leading Novartis' largest business unit, Novartis Pharmaceuticals president Marie-France Tschudin talked to Scrip about the US launch of inclisiran, US drug price reform and other challenges and opportunities for the industry.