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UK doctors raise concerns about the safety of lipid-lowering agent inclisiran

Novartis faced a hurdle with the rollout of inclisiran (brand name: Leqvio), a cholesterol-lowering drug, in Europe.

British medical groups have raised concerns over the agreement between Novartis and the British government to distribute the drug at a reduced price.

British medical groups have raised concerns about the safety of Novartis’ cholesterol lowering medicine, Leqvio (inclisiran).

The British Medical Association (BMA) and the Royal College of General Practitioners (RCGP) have called on the British government to reconsider the marketing of inclisiran in primary care.

In September, Novartis and the National Health Service agreed to make inclisiran more accessible at a drastically reduced price for the first time in the world.

As part of the deal, Novartis planned to deliver inclisiran to around 300,000 people in primary care across the UK at a reduced price to prevent secondary cardiovascular disease.

However, BMA and RCGP pointed out that inclisiran was a ‘black triangle drug’, or a drug with a new mechanism or form, and that there were still questions to be resolved regarding the release of the drug. .

BMA and RCGP said that inclisiran lacks long-term data on cardiovascular outcomes, and relevant studies are not available until 2026.

“There is a lack of long-term safety data and as yet unknown potential long-term side effects and interactions of the drug,” they said in a statement.

They also questioned whether primary care has the capacity to use additional resources to deliver this new drug at a time of unprecedented demand and shortage of healthcare workers amid Covid-19.

While finding the answers to these questions, BMA and RCGP said they would encourage doctors to continue treating patients with high cholesterol following lipid guidelines, focusing on all options, including lifestyle changes, statins, high intensity statins and ezetimibe, and injections if needed.

If primary care clinicians initiate inclisiran, they should be aware that they will take full responsibility for prescribing as the decision maker, they added.

If doctors decide to prescribe inclisiran, they should share knowledge with the patient about the lack of long-term data and the unknown long-term safety profile of the new drug and obtain informed consent, BMA said and RCGP.

Physicians should also encourage patients to report all side effects, even minor ones, and should complete an MHRA (Medicines and Health Products Regulatory Agency) report on side effects, any potential drug interactions, or their own concerns. as soon as possible.

“This approach will allow early identification of any as yet unknown issues and will help inform how the drug can be used in the future, as well as the trial data that is expected to be released in 2026,” BMA and RCGP said. .

Inclisiran is the first small interfering RNA (siRNA) agent to lower LDL cholesterol (LDL-C) by blocking proprotein convertase subtilisin / kexin type 9 (PCSK9) in the liver.

In the phase 3 ORION trials (ORION-9, 10, 11), inclisiran showed a 50% reduction in LDL-C.

The effect was non-inferior to that of Amgen Repatha’s anti-PCSK9 monoclonal antibody (evolocumab) and Sanofi’s Praluent (alirocumab).

While existing anti-PCSK9 monoclonal antibodies require 26 injections per year, inclisiran can only be given twice per year to cause the same effect.

Novartis obtained marketing authorization for inclisiran in Europe in late 2020 and expects to obtain FDA clearance in January 2022.

In Korea, Novartis plans to complete the approved clinical trial in June 2022 and prepare for a global release of the drug.

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