Combination therapy shows promise for transplanting HCV-infected organs
The drug is now in its Phase III development for secondary prevention patients with expected European Medicines Agency (EMA) regulatory filing the first quarter of 2020. The proposal for the drug to be administered in large scale NHS clinical trial, which is the first in the world to treat that patient population. The NHS will also evaluate and assess the approach to reduce the risk of heart disease.
The treatment, which is like a vaccine, will be first trialed on 40,000 middle-aged men and women whose cholesterol levels remained high even if they consume their daily dose of statins. However, starting from next year, the drug will be tested on around 300,000 patients a year. Estimates suggest that the drug can help prevent about 55,000 heart attacks and strokes in a decade, which can save 30,000 lives.
“This innovative and groundbreaking collaboration could transform the health outlook of tens of thousands of people suffering from heart disease, by bringing together in a unique combination our ability to organize large scale clinical trials, to address highly complex manufacturing issues, and to reach a large population of patients,” Lord Prior, chair of NHS England, said.
“It is a great illustration of how the UK Life Sciences Strategy can help both NHS patients and the wider economy and shows that the UK can be the center of a dynamic life sciences ecosystem whilst delivering great care,” he added. Atherosclerosis and cardiovascular disease risk
High triglycerides and cholesterol levels may lead to atherosclerosis, a condition that involves the hardening of the arteries . It can reduce the blood flow and when it blocks the arteries, it can lead to serious and potentially fatal conditions such as heart attack and stroke.
In atherosclerosis, plaque, which is made of cholesterol, fat, calcium and other substances in the blood, accumulate inside the arteries. In the long run, the plaque hardens and narrows the arteries, limiting blood flow with oxygen and nutrients to vital organs and other parts of the body. Source:
Department of Health and Social Care, NHS England, Office for Life Sciences, and Department for International Trade. (2020). UK Government tackles heart disease with new partnership. https://www.gov.uk/government/news/uk-government-tackles-heart-disease-with-new-partnership