Novartis: FDA rejects new cholesterol drug
(CercleFinance.com) - A potential treatment for hyperlipidemia in adults who have elevated cholesterol levels, which was developed by Switzerland's Novartis, has been rejected for marketing in the US.
The Food and Drug Administration issued a so-called "complete response letter," which indicates that the new drug application for inclisiran cannot be approved in its present form, the drugmaker said.
The FDA stated that it cannot approve the application by the action date of 23 December due to unresolved facility inspection-related conditions.
Novartis said it will work with the third-party facility which is responsible for drug manufacturing in Europe to complete the review, to bring the treatment to US patients "as quickly as possible".
With two doses a year, inclisiran is administered in-office as a subcutaneous injection.
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