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Dive Brief: The Food and Drug Administration last week informed Novartis that it would not be able to complete its review as scheduled of the Swiss drugmaker s closely watched cholesterol drug inclisiran, issuing a complete response letter that could delay a decision on approval for months. At issue are unresolved conditions related to an as-yet unscheduled inspection of a facility in Italy where Novartis manufactures inclisiran. Due to the coronavirus pandemic, FDA inspectors haven t been able to visit and inspect the site.  Novartis emphasized the FDA s letter did not raise any issues with either the safety or efficacy of inclisiran, which was shown in clinical testing to significantly reduce cholesterol levels in people already taking statins. The pharma hopes to quickly resolve the remaining conditions but, should an inspection be required, completion of inclisiran s review would be delayed until the FDA restarts foreign country inspections. 

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