Inclisiran?

What is Inclisiran, and how does it work?

Inclisiran is an experimental lipid-lowering medication being developed by The Medicines Company (MDCO) and now owned by Novartis [1] (as of May 2022). It is an RNA interference (RNAi) therapy, targeting the PCSK9 gene, which plays a significant role in cholesterol levels.

How does Inclisiran compare with Statins and PCSK9 inhibitors?

Unlike traditional statins, Inclisiran targets the PCSK9 gene to reduce the production of low-density lipoprotein (LDL) cholesterol. It has been shown to significantly lower LDL cholesterol levels, including those not responding to statins [2]. However, the impact of Inclisiran on cardiovascular outcomes remains to be seen in long-term clinical trials.

What are the current clinical status and regulatory approvals?

Inclisiran has received positive results in numerous phase III clinical trials. Notably, the Soundbox study [3] and the ORION-9 trial [4] demonstrated a substantial drop in LDL cholesterol levels. Regulatory approvals have been granted in several countries, including the European Union and parts of Asia [5].

How does Inclisiran interact with other medications and potential side effects?

The primary concern is its potential impact on patients with certain genetic conditions. For instance, those with homozygous familial hypercholesterolemia should be cautious of using Inclisiran alongside other cholesterol-lowering medications [6]. While generally safe, Inclisiran may trigger adverse reactions, such as gastrointestinal issues, but these effects are typically mild [2].

What is the future of Inclisiran, including the market competition and pricing?

As Novartis prepares to market Inclisiran, it faces competition from existing PCSK9 inhibitors. The price of Inclisiran is not yet publicly disclosed, but it is expected to be competitive with established therapies [7].

Patent expiration and biosimilars

According to DrugPatentWatch.com [8], two U.S. patents related to Inclisiran are expected to expire in 2034.

References:

[1] https://www.novartis.com/news-media/press-releases/en/2022/12142022
[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7416545/
[3] https://clinicaltrials.gov/ct2/show/NCT03397117
[4] https://clinicaltrials.gov/ct2/show/NCT04243421
[5] https://www.eur-lex.europa.eu/eli/medicinal-product/authorisation/human/completed/EURD-2021-1150
[6] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7314396/
[7] https://www.novartis.com/news-media/investor-relations/innovative-business
[8] https://www.drugpatentwatch.com/drug/inclisiran