PCSK9 inhibitors are a new class of drugs that are prescribed to treat hypercholesterolemia (high blood cholesterol). They help lower LDL (bad) cholesterol.
Currently, there are two FDA-approved PCSK9 inhibitors – Praluent (alirocumab) and Repatha (evolocumab). These drugs are advised to people with hypercholesterolemia who do not respond to statins.
These drugs have struggled with sales since the approval of other medications, such as Leqvio (inclisiran), and Nexletol (bempedoic acid) and Nexlizet (ezetimibe).
Price has been one of the issues. For instance, Repatha and Praluent have run around $14,000 for a year’s supply, while statins cost about $50 per month, which is why people have been reluctant to pay for these drugs.
Michigan-based Esperion, which manufactures Nexletol and Nexlizet, has struggled to launch its drugs. They tried to launch the drugs when the COVID-19 pandemic was at its peak.
Last month, the company announced plans to cut its overall workforce by 40% and decrease operational expenses in fiscal years 2021 and 2022, according to BioSpace. They hope to save at least $80 million with the moves.
Now, Merck has presented data at the American Heart Association Meeting on its experimental drug MK-0616, which is also a PCSK9 inhibitor, according to BioSpace.
Repatha and Praluent may face a big challenge if Merck is able to bring its drug to the finishing line, which is now in its Phase I trials.
The results of the trials have shown that Merck’s drug decreases LDL cholesterol by about 65%. Repatha decreases LDL by about 55% and Praluent by about 58%.
Clinical Director at Merck Douglas Johns said, “The initial results are encouraging; however, more clinical studies are needed to confirm these findings, given limited clinical experience with the molecule MK-0616.”
When asked about the potential price of MK-0616, Johns said it was too early to discuss it. However, he said the company would be taking the price factor “very seriously.”
Apart from the higher efficacy, MK-0616 can be taken orally, which is not the case with Repatha and Praluent, which are injectable medicines.