FDA rejects Novartis' cholesterol drug after factory inspection issue

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Novartis’ cholesterol drug inclisiran has hit a speed bump with the FDA, which has rejected the potential blockbuster because a manufacturing facility has yet to be inspected.

Matters appear to have been complicated by the pandemic and the travel disruption that it has caused, which is preventing an FDA team from visiting the plant in Europe.

In a statement the Swiss pharma said that the FDA has not raised any concerns about the safety or efficacy of the drug, which Novartis added to its pipeline after buying The Medicines Company for $9.7 billion late last year.

A first-in-class treatment discovered by Alnylam and then licensed to The Medicines Company, the drug is being developed for treatment for hyperlipidaemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy.

The FDA was due to make a regulatory decision on inclisiran by Wednesday but this has been delayed because of the unresolved “facility inspection-related conditions”.

Novartis said it will receive these requirements at the European manufacturing facility within 10 business days.

The FDA has not yet conducted a facility inspection and the FDA will set out a schedule if it deems one necessary, once safe travel may resume.

The European Commission has already approved the drug under the brand name Leqvio earlier this month following backing from the CHMP regulatory committee.

Inclisiran is a small interfering RNA (siRNA) therapy that works by inhibiting PCSK9 – the same target as Amgen’s Repatha (evolocumab) and Sanofi/Regeneron’s Repatha (alirocumab) – but is dosed only twice a year rather than every month.

Novartis hopes that the drug will make an impact where these antibody drugs have failed, with Repatha and Praluent lacking sales momentum despite being on the market for more than five years.

Payers had deemed the drugs to be too expensive and even price cuts failed to expand their use.

In January, Novartis and NHS England forged a pact to accelerate access to inclisiran for primary prevention of cardiovascular disease.