The U.S. Food and Drug Administration approved Leqvio (inclisiran) on December 22, 2021. The approval was recorded under NDA 214012, and the FDA summary identified Novartis as the sponsor. The supplied record classified the application as a Type 1 new molecular entity.
Background
Inclisiran is listed in the record under the names inclisiran, Leqvio, and inclisiran sodium. The event was identified as an initial FDA approval. The supplied data do not state the approved indication, patient population, dosing schedule, mechanism of action, or clinical results, so those details are not described here.
Approval details
The FDA event concerned the approval of Leqvio (inclisiran) through NDA 214012. The event type was FDA initial approval, dated December 22, 2021. The record’s classification, “Type 1 - New Molecular Entity,” identifies the application category provided in the FDA summary.
What this means
This entry documents that the FDA approved Leqvio under NDA 214012 on the stated date. It also establishes the sponsor and the application’s new-molecular-entity classification. The supplied event record does not include the approved use, prescribing information, trial endpoints, efficacy measurements, safety findings, or comparisons with other treatments. Those questions require review of the FDA’s associated labeling and supporting documents rather than this approval-entry summary.
Source
Source: U.S. Food and Drug Administration, Drugs@FDA application overview for NDA 214012, dated December 22, 2021. The authoritative record is hosted at accessdata.fda.gov: https://accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA214012.