Fda sends full response letter! Novart's U.S. launch of the heavyweight RNAi lipid-lowering drug has been delayed

The FDA has not questioned the efficacy and safety of inclisiran, which is related to the production process.
The FDA said in its letter that it would notify the European-based plant within 10 working days of the issue, given that some of the issues identified during the review of the production plant's data had not been resolved and that the application for listing could not be approved by the PDUFA date of December 23, 2020.
a third-party factory responsible for inclisiran's production, and the FDA said it would not approve the drug's application for market until the issues found by the inspection were satisfactorily resolved.
the FDA has not yet conducted on-site inspections of the plant, if on-site inspections are necessary, the FDA will take into account the epidemic situation and other safety factors after the flight inspection itinerary.
, Novart's head of global drug development and chief medical officer, said: "We are confident in the quality of inclisiran and we have presented strong in vivo efficacy and safety evidence in our listing applications.
we will meet with the FDA and our third-party production partners as soon as possible to discuss feedback on the issues and our next steps.
we will bring this first in class's innovative small molecule RNAi fat-lowering therapy to patients as soon as possible.
" Inclisiran, developed by Alnylam Pharmaceuticals, is a small interfering RNA drug for first in class that reduces LDL-C.
Company acquired Inclisiran's exclusive global development and commercial license, and Novartic will pocket Inclisiran through its $9.7 billion acquisition of The Medicines Company by the end of 2019.
inclisiran was injected under the skin, three months between the first two doses and one every six months therein.
December 11th, the European Union approved Leqvio's listing application for treatment of hypercholesterolemia and mixed lipid abnormalities in adults.
approval in the EU is based on positive results from ORION research.
results showed that Inclisiran reduced LDL-C by up to 52% in patients who were still unable to meet the standards after treatment with the highest to-to-do statins.
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