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Novartis Side Steps FDA’s Manufacturing Inspection Concerns

Following an unexpected FDA rejection late last year, Novartis is attempting to resurrect the cardiac medication Leqvio. However, instead of risking a further delay by relying on a third-party facility to make adjustments, Novartis is taking matters into its own hands.announced Tuesday that it had resubmitted Leqvio, or inclisiran, to the FDA with a new manufacturing location.

According to Novartis, the FDA rejected the medicine in December, citing “unresolved facility inspection-related problems,” according to Novartis. As a result, the company is now moving finished PCSK9 med production from an Italian unit managed by Corden Pharma to its facility in Schaftenau, Austria. Novartis began transferring technology to the Austrian location before the FDA’s rejection, the company announced Tuesday.

CEO Vas Narasimhan indicated at the time that the company had completed the process by April. Despite the FDA’s rejection, the European Union approved the medication in December, with the Italian facility functioning as the manufacturing plant. However, due to pandemic constraints, the FDA had to rely on a paper-based examination of the location.

In 2019, Novartis paid $9.7 billion for The Medicines Company, which included Leqvio. The corporation thought that the late-stage potential would generate significant sales soon at the time. However, even before the regulatory snafu, industry analysts had expressed reservations about the drug’s efficacy. In addition, due to a pricing war, other PCSK9 antibody medications, such as Amgen’s Repatha and Sanofi and Regeneron’s Praluent, have yet to live up to their blockbuster expectations.

Aside from the inspection-related rejection, the pandemic has had an impact on a pivotal medication trial. Because the pandemic hindered patient enrollment in the United Kingdom, Novartis has pushed back the readout for the crucial cardiovascular outcomes trial, dubbed ORION-4, to 2026 from 2024, according to Novartis Chief Medical Officer John Tsai, M.D.

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