FDA has Officially recognized A new cholesterol-lowering drug from Novartis and two commercial drugs from Amgen and Regeneron solve the same goal, but have different methods and key dosage advantages—it only needs to be injected twice a year.
The drug, called inclisiran, is part of a relatively new class of genetic drugs that works by preventing the production of problematic proteins. Take Novartis’s drug as an example. The drug will be marketed under the name Leqvio, and the target is PCSK9, a liver protein. The large amount of it will hinder the body’s ability to remove low-density lipoprotein cholesterol, which is the “bad” form of cholesterol. Leqvio is composed of small interfering RNA, which uses a cellular mechanism called RNA interference to prevent genes from producing PCSK9.
The way Leqvio and other RNAi drugs work is sometimes called gene silencing. It is different from PCSK9 inhibitors, which are the antibody drugs Repatha and Praluent from Amgen and Regeneron, respectively. Both drugs are injected subcutaneously every two weeks or monthly, and both were approved in 2015. However, their high price tags make it difficult for them to sell to payers, and their income is lower than initially expected. In 2018, Amgen reduce The price of Repatha has increased by nearly 60%, bringing the drug’s list price to $5,850 per year. A few months later, Regeneron matched the pricing action of its PCSK9 blocking drug.
The approval of Amgen and Regeneron drugs covers heterozygous familial hypercholesterolemia, a genetic disease that can lead to dangerously high cholesterol levels, which can lead to heart disease, heart attack, and stroke. Leqvio’s approval covers the same indications, but it also includes a larger group: about 30 million Americans accumulate cholesterol in their arteries, which is called clinical atherosclerotic cardiovascular disease. Novartis drugs are suitable for diet and statin therapy, which is a commonly used cholesterol-lowering drug.
As Leqvio initially knew, Inclisiran came from the laboratory of Alnylam Pharmaceuticals, a biotechnology company based in Cambridge, Massachusetts, which was the first to receive FDA approval for Onpattro’s RNAi drug. Alnylam licensed inclisiran to The Medicines Company, which passed Phase 3 testing. MedCo is preparing to apply for FDA approval in 2019, when Novartis reached a deal to acquire the entire company for US$9.7 billion.
The FDA’s review of Leqvio is based on the results of three phase 3 clinical trials, which enrolled a total of 3,457 patients. These results indicate that at the 17th month, patients who received Leqvio had a 52% reduction in cholesterol levels compared to patients who received placebo. Side effects such as injection site reactions, joint pain, urinary tract infection, and diarrhea were comparable in the two studies.
Leqvio treatment starts with the initial dose and then another dose at three months. The twice-yearly dosing schedule begins six months later. Novartis said this schedule may help patients who have difficulty taking medications on their own or have to take medications more frequently. Novartis sets a price of US$3,250 per dose of Leqvio. This means that in the patient’s first year of treatment, three injections will cost US$9,750. After that, the annual price will be $6,500.
The Institute of Clinical and Economic Review, a drug price regulator, concluded in January this year that Novartis’s evidence is more favorable than conventional care, and Respected Prices range from US$3,600 to US$6,000 per year.
Leqvio’s approval was approved by the FDA one year later Refuse Novartis’ drug application cited manufacturing issues. Novartis said that Leqvio will be listed in early January.
Photo by Novartis
