AGEPHA Pharma’s LODOCO gets US FDA approval for cardiovascular disease
2023-06-21
上市批准临床结果AHA会议
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来源: Pharmaceutical Technology
LODOCO is indicated for reducing the risk of stroke, myocardial infarction and cardiovascular death in adult ASCVD patients. Credit: AGEPHA Pharma/ Business Wire.
AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 mg tablet) to treat cardiovascular disease.
LODOCO is indicated for reducing the risk of stroke, myocardial infarction and cardiovascular death in adults with established atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for the disease.
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It has been designed to target residual inflammation as an underlying cause of ASCVD.
It can be used as a monotherapy or along with cholesterol-lowering medicines.
It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator.
The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.
Participants treated with LODOCO had a 31% reduction in the overall risk of cardiovascular death, spontaneous myocardial infarction or ischaemic stroke when added to statins and other cardiology prevention therapies, compared to those treated with placebo.
AGEPHA Pharma managing director Antonia Riel-Köllmann stated: “As the third generation of my family dedicated to developing high-quality European pharmaceuticals, it’s a privilege to bring this life-sustaining therapy, which represents the company’s first product launch in the US, to the global market.
“We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.”
The company expects to launch LODOCO for prescription use in the second half of 2023.
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