Novartis (NYSE: NVS) has resubmitted paperwork to the FDA for inclisiran, a subcutaneously-delivered drug candidate for treating hyperlipidemia in adults whose low-density lipoprotein cholesterol (LDL-C) remains elevated after taking a maximum tolerated dose of statin therapy.
In Dec. 2020, FDA issued a complete response letter (CRL) for inclisiran. A CRL indicates that the agency has decided not to approve a new drug application. In this case, FDA had expressed concern over unresolved inspection-related conditions at an Italian contract development and manufacturing organization (CDMO).
In a statement, Novartis announced that it plans to shift inclisiran production to its facility in Schaftenau, Austria. The company said it planned to move production of the drug to that plant before it received the CRL.
In its CRL, FDA did not relay concerns related to the safety or efficacy of inclisiran.
Novartis won EU approval for the drug in December.
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