FDA Grants Tina-qant Lp(a) Assay Breakthrough Device Designation

The FDA has given a lipoprotein(a) (Lp[a]) assay (Tina-qant; Roche) breakthrough device designation, allowing for further identification of patients with elevated Lp(a) and a history of atherosclerotic disease who may benefit from Lp(a)-lowering therapy. Approximately 20% to 30% of people worldwide are estimated to have elevated levels of Lp(a), which has been shown to be an important genetic risk factor for cardiovascular disease (CVD).³ The designation for the assay marks the FDA’s effort to expand access to treatment for patients with elevated Lp(a) levels, who have increased risk of heart attack, stroke, and other related conditions.

A lipoprotein(a) assay will allow for further identification of patients with elevated Lp(a) and a history of atherosclerotic disease who may benefit from therapy.

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Lp(a) is a genetically inherited lipoprotein particle in the body, composed of proteins and lipids; it is associated with the transfer of cholesterol, fats, and proteins in the blood, such as low-density lipoprotein (LDL) cholesterol. It has a similar structure to LDL that consists of apolipoprotein B (apoB100) and is connected to apolipoprotein(a) (apo[a]). When apo(a) attaches to apoB100, it disrupts LDL receptor-mediated catabolism, leading to prolonged circulation of Lp(a) in the blood that contributes to atherosclerosis and CVD.^4-6

Due to Lp(a)'s ability to promote the buildup of lipids and subsequent plaque development, elevated levels in the blood increase risk factors such as heart attack, stroke, aortic stenosis and peripheral artery disease.⁴ Study findings show Lp(a) levels are predominantly (> 90%) determined by genetic mutations of the LPA gene. However, non-genetic factors, such as menopause or hyperthyroidism, can also influence elevated Lp(a) levels in the blood. Data also show additional factors such as ethnicity—as there is a prevalence of raised levels among Black women—and pre-existing conditions, including diabetes or chronic kidney disease, can increase individuals’ risk of developing high Lp(a) levels.¹

The Lp(a) assay is a blood test that measures the number of Lp(a) molecules per litre in the bloodstream (nmol/L) instead of molecular weight in the blood (mg/L), unlike currently available tests. Lp(a) has no defined molecular weight, leading the scientific community to establish that levels should be measured in terms of the nmol/L for most accurate results. Levels greater than 125 nmol/L are considered high and may require further attention. Health care professionals and associations, including the European Atherosclerosis Society and the Canadian Cardiovascular Society, recommend testing Lp(a) at least once in all adults, regardless of family history.⁵

FDA's breakthrough device designation for the Lp(a) assay marks notable advancements in identifying and treating patients with elevated Lp(a) levels and a history of atherosclerotic disease. The decision opens avenues for improved risk assessment and targeted therapy for individuals at heightened risk of cardiovascular events, reducing the burden of CVD and improving patient outcomes.

REFERENCES

1. Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk. Roche. May 22, 2024. Accessed May 22, 2024.

2. Data Show Lepodisiran Was Well Tolerated, Substantially Lowered Lipoprotein (a). Pharmacy Times. November 13, 2023. Accessed May 22, 2024. https://www.pharmacytimes.com/view/data-show-lepodisiran-was-well-tolerated-substantially-lowered-lipoprotein-a-

3. Lipoprotein(a): What to know about elevated levels. National Heart, Lung, and Blood Institute. January 17, 2024. Accessed May 22, 2024. https://www.nhlbi.nih.gov/news/2024/lipoproteina-what-know-about-elevated-levels#:~:text=Today%2C%20about%2020%2D30%25,inherited%20risk%20for%20cardiovascular%20disease.

4. Lipoprotein (a). American Heart Association. Accessed May 22, 2024. www.heart.org. https://www.heart.org/en/health topics/cholesterol/genetic-conditions/lipoprotein-a

5. Ciffone N, McNeal CJ, McGowan MP, Ferdinand KC. Lipoprotein(a): An important piece of the ASCVD risk factor puzzle across diverse populations. Am Heart J Plus. 2023;38:100350. doi:10.1016/j.ahjo.2023.100350

6. Innerarity TL, Boström K. Mutations and variants of apolipoprotein B that affect plasma cholesterol levels. Adv Exp Med Biol. 1991;285:25-31. doi:10.1007/978-1-4684-5904-3_2