Parsippany, NJ – June 20, 2023 -- AGEPHA Pharma USA, LLC, today announced that, following a Priority Review, the U.S. Food and Drug Administration (FDA) has approved Lodoco® as the first anti-inflammatory atheroprotective cardiovascular treatment demonstrated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.1

AGEPHA Pharma anticipates that Lodoco, which can reduce the risk of cardiac events in patients with established cardiovascular diseases by 31%2 on top of standard of care, will be available for prescription in the second half of 2023.

Clinical Evidence of Lodoco for Heart Attack and Stroke Prevention

The effectiveness and safety of Lodocoin preventing heart attack and stroke is supported by randomized trial data reported in the New England Journal of Medicine, Circulation, Journal of the American College of Cardiology, and European Heart Journal, while data emphasizing the critical need to address inflammation as much as cholesterol in heart disease patients has been recently described in The Lancet.

The multi-national, randomized, double-blind, placebo-controlled clinical trial was conducted among 5,522 patients with chronic coronary disease all of whom were taking guideline-directed medical care including high-intensity statins. In the trial, 0.5 mg colchicine was found to significantly reduce the overall risk of cardiovascular death, spontaneous myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization by 31% in comparison with the placebo group when added to high-intensity statins and other cardiology prevention therapies (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.57 to 0.83; P<0.001).2

Entering a New Era of Patient Care

It has been long understood that inflammation as well as high cholesterol increases cardiovascular risks.

“Approval by the FDA of the first drug to target cardiovascular inflammation is an important step forward for the care of our patients,” said Paul Ridker, MD, MPH, professor of medicine, Harvard Medical School and director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital, who has been instrumental in elucidating the role of inflammation in cardiovascular disease. Dr. Ridker added, “To treat coronary disease effectively, cardiologists must aggressively reduce inflammation and cholesterol. For appropriate patients already taking a statin, adding the anti-inflammatory drug colchicine at a dose of 0.5 mg daily has been proven to significantly lower risks of recurrent heart attack and stroke.”

A recent study in The Lancet, on which Dr. Ridker served as lead author, demonstrated that among contemporary statin-treated patients, vascular inflammation strongly predicts future cardiovascular events – perhaps even more than high cholesterol.

Reduce Inflammation, Reduce Plaque Formation

Inflammation plays a critical role in Atherosclerotic Cardiovascular Disease (ASCVD). ASCVD is a condition where the arteries become narrowed and hardened due to the buildup of plaque, which can lead to heart attacks and strokes3 and refers to conditions including coronary artery disease, acute coronary syndrome, peripheral artery disease, and cerebrovascular disease. Patients with ASCVD, the leading cause of morbidity and mortality in the United States4, are at high risk for acute cardiovascular events.5

The formation of atherosclerotic plaque, in which inflammation plays a substantial role, contributes to the development and progression of ASCVD.6 Lodocoinhibits microtubule assembly and has multiple anti-inflammatory mechanisms.7,8 High-sensitivity C-reactive protein (hs-CRP) is the inflammatory biomarker most widely used to predict residual inflammatory risk and ASCVD outcomes.9

Michael Blaha, MD, MPH, director of clinical research and professor of medicine at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease said, “For the first time, patients with residual inflammatory risk, as measured by hs-CRP, will have an FDA-approved treatment option demonstrated to reduce the risk of cardiovascular disease by targeting the inflammatory pathways that influence major cardiac events.”

Dr. Blaha added, “The cardiovascular research community has demonstrated that focusing on unmet patient medical needs and addressing the long-standing challenge of reducing cardiac inflammation can translate into meaningful risk reduction in the incidence of cardiac events.”

Disease burden in the United States

Lodoco’s Place in Therapy

Lodocotablets are formulated as a once-daily, continuous-use oral treatment for adults and can be used safely alone or in combination with standard-of-care lipid-lowering medications and other therapies, to effectively reduce the risk of heart attack and stroke.

Patients with kidney failure or severe liver disease should not take Lodoco. Patients should temporarily stop taking Lodocoif prescribed certain drugs like azithromycin or ketoconazole as these medications should not be taken simultaneously.

Groundbreaking Therapy Championed by EU-Founded, Family-Led Pharma Company

Antonia Riel-Köllmann, managing director of AGEPHA Pharma, the family owned and operated company 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 United States, to the global market. We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to Lodoco.”

About AGEPHA Pharma

AGEPHA Pharma is a family-owned, leading multinational pharmaceutical company focused on bringing treatments to patients who need them most. Since 1947, they have invested in proven therapies, including a wide range of pharmaceuticals, medical devices, and nutritional supplements, supported by a highly qualified team of clinical scientists and regulatory experts.

For more information, please visit AGEPHA Pharma’s U.S. corporate website or follow AGEPHA Pharma on Twitter (@AGEPHAPharmaUS) and LinkedIn.

IMPORTANT SAFETY INFORMATION

Indication

Lodoco is indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

IMPORTANT SAFETY INFORMATION LODOCO (COLCHICINE) 0.5 MG TABLETS

Do not take Lodoco if you:

• take certain medicines called strong CYP3A4 inhibitors or P-glycoprotein inhibitors. Ask your healthcare provider if you are not sure. Taking certain medicines with Lodoco may cause your level of Lodoco to be too high in your body and cause life-threatening side effects or death.
• have severe kidney or liver problems.
• have blood problems.
• are allergic to colchicine or any of the ingredients in Lodoco.

What are the possible side effects of Lodoco?

Lodoco may cause serious side effects, including:

• Blood problems. Lodoco can cause low red blood cell counts, low white blood cell counts, and low platelet counts, which can be life-threatening or may lead to death.
• Muscle weakness (neuromuscular toxicity). Lodoco can cause muscle weakness and muscle problems.

The most common side effects of Lodoco include:

• diarrhea, vomiting, and stomach-area (abdominal) cramping.
• muscle pain

Fatal overdoses have been reported with colchicine in adults and children. Keep Lodoco out of the reach of children.

References:

1 Lodoco. Prescribing information. AGEPHA Pharma FZ LLC; 2023.

2 Nidorf SM, Fiolet ATL, Mosterd A, et al. Colchicine in Patients with Chronic Coronary Disease. N Engl J Med. 2020;383(19):1838-1847. doi:10.1056/NEJMoa2021372

3 What is atherosclerosis? American Heart Association. Published April 3, 2023. Accessed April 12, 2023. https://www.heart.org/en/health-topics/cholesterol/about-cholesterol/atherosclerosis

4 Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines [published correction appears in Circulation. 2019 Sep 10;140(11):e649-e650] [published correction appears in Circulation. 2020 Jan 28;141(4):e60] [published correction appears in Circulation. 2020 Apr 21;141(16):e774]. Circulation. 2019;140(11):e596-e646. doi:10.1161/CIR.0000000000000678

5 van Trier TJ, Snaterse M, Hageman SHJ, et al. Unexploited potential of risk factor treatment in patients with atherosclerotic cardiovascular disease. Eur J Prev Cardiol. 2023;30(7):601-610. doi:10.1093/eurjpc/zwad038

6 Libby P, Ridker PM, Hansson GK. Progress and challenges in translating the biology of atherosclerosis. Nature. 2011 May 19;473(7347):317-25. doi: 10.1038/nature10146. PMID: 21593864.

7 Leung YY, Yao Hui LL, Kraus VB. Colchicine–Update on mechanisms of action and therapeutic uses. Semin Arthritis Rheum. 2015;45(3):341-350. doi:10.1016/j.semarthrit.2015.06.013

8 Zhang FS, He QZ, Qin CH, Little PJ, Weng JP, Xu SW. Therapeutic potential of colchicine in cardiovascular medicine: a pharmacological review. Acta Pharmacol Sin. 2022;43(9):2173-2190. doi:10.1038/s41401-021-00835-w

9 Rossello X, et al. Lifetime Risk Estimation in Atherosclerotic Cardiovascular Disease. J Am Coll Cardiol. 2021 Sep, 78 (11) 1095–1096. https://doi.org/10.1016/j.jacc.2021.07.035

10 Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FNet al. Heart disease and stroke statistics-2021 update: a report from the American Heart Association. Circulation. 2021; 143:e254–e743. doi: 10.1161/CIR.0000000000000950

11 Ritchey MD, Wall HK, Owens PL, Wright JS. Vital Signs: State-Level Variation in Nonfatal and Fatal Cardiovascular Events Targeted for Prevention by Million Hearts 2022. MMWR Morb Mortal Wkly Rep. 2018;67(35):974-982. Published 2018 Sep 7. doi:10.15585/mmwr.mm6735a3

12 Heart disease and stroke. Centers for Disease Control and Prevention. Published September 8, 2022. Accessed April 25, 2023. https://www.cdc.gov/chronicdisease/resources/publications/factsheets/heart-disease-stroke.htm

13 Tsao CW, Aday AW, Almarzooq ZI, et al. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association [published correction appears in Circulation. 2022 Sep 6;146(10):e141]. Circulation. 2022;145(8):e153-e639. doi:10.1161/CIR.000000000000105

Source: AGEPHA Pharma USA, LLC

Posted: June 2023