Bempedoic acid may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the arm, shoulder, or Achilles' tendon of the heel. 3 Speen Street, Suite 300, Framingham, MA 01701. Pfizer's former R&D executive and Forbes columnist John LaMattina said on Twitter this morning: "My guess is that the FDA will require the results of Esperion's CV outcomes study before approval. Enclose phrases in quotes. Join Thermo Fisher Scientific’s upcoming webinar to learn why softgels offer numerous benefits for Rx drug development, including enhanced bioavailability, patient compliance and easy scale-up. Not all possible drug interactions are listed here. Though the trial excluded patients who had had a significant cardiovascular event within three months of enrolling, the company said the safety results were as expected—and that previous trials covering that early timeline did not produce cause for alarm. In the current study, there were no deaths due to … Select one or more newsletters to continue. All rights reserved. The phase 3 trial met its endpoints in safety and efficacy, including a 22% reduction in high-sensitivity C-reactive protein, and Esperion expects to submit applications to the FDA in the first quarter of 2019, and in Europe by the second quarter. Patients who cannot tolerate a statin‐based treatment regimen present a particular challenge for lipid management and cardiovascular event risk reduction.1, 2 Registries and observational studies have reported statin intolerance prevalence rates of 7% to 29%, with the predominant symptoms being muscle‐related side effects.3 Statin‐associated muscle symptoms account for >90% of side effects attributed to statins4 and contribute to the high rate of nonadherence and discontinuation frequently ob… Another five deaths were cardiovascular-related, with most events occurring within the first 60 days. Reproduction in whole or part is prohibited. Tendon problems may be more likely in certain people (older adults, people with kidney disease, or people who take steroid medicine or certain antibiotics. This can happen within days or months after you start taking bempedoic acid. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. However, many risk factors contribute to ASCVD including smoking, hypertension, obesity, physical inactivity, poor nutrition, and other clinical conditions (e.g., diabetes, metabolic syndrome). Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Five of the deaths in the treatment arm were related to lung cancer, with most seeing tumors discovered within the first three months of the study. 9 In this trial, approximately 8.4% of the participants continued their tolerated low-dose statin therapy. The primary endpoint of the study is the effect of bempedoic acid on major adverse cardiovascular events (cardiovascular death, non-fatal myocardial … The short timeline made it highly unlikely that those events were caused by bempedoic acid, Sasiela said. exclude terms. You should not breastfeed while using bempedoic acid. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. In the bempedoic acid group, there were five deaths that appeared to be related to cardiovascular disease, five due to cancer, two caused by gastrointestinal problems such … low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet. The company expects results from three more phase 3 studies in the coming months, examining bempedoic acid alone and in combination with ezetimibe, also known as Merck’s Zetia. The company’s initial press release categorized the adverse events as unrelated to the treatment, with deaths listed in a separate chart (much to the chagrin of Bio-Twitter), but did not offer an immediate explanation. This is not a complete list of side effects and others may occur. There's also the issue that more patients died on bempedoic acid compared to placebo in this trial. Store at room temperature away from moisture and heat. You may report side effects to FDA at 1-800-FDA-1088. Bempedoic acid is also used to lower LDL cholesterol in adults with coronary artery disease (clogged arteries). © 2020 Questex LLC. Other drugs may affect bempedoic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. At least not in the text of the company’s press release. Stop taking bempedoic acid and seek medical attention right away if you have signs of tendon rupture: sudden pain, swelling, bruising, or tenderness; or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions). In 2017, CV disease was listed as the underlying cause of death in approximately 859,125 US patients. In CLEAR Harmony, new-onset or worsening diabetes occurred in 3.3% of patients who received bempedoic acid vs 5.4% of patients who received placebo. Esperion’s phase 3 LDL study raises flags with treatment-arm deaths, Esperion’s LDL drug flies through phase 2 as add-on treatment, Polyphor snags $3.3M for inhaled antibiotic, Fancy a Black Friday R&D deal? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Bempedoic acid is for use in adults with an inherited form of high cholesterol. Bempedoic acid is used together with diet and other medicines to lower blood levels of "bad" cholesterol (low-density lipoprotein, or LDL). Data sources include IBM Watson Micromedex (updated 2 Nov 2020), Cerner Multum™ (updated 2 Nov 2020), ASHP (updated 23 Oct 2020) and others. Esperion unveiled top-line results from a yearlong phase 3 trial of bempedoic acid, showing it can lower LDL cholesterol levels by an additional 20% over 12 weeks in high-risk patients taking statins. Given that the bempedoic acid mechanism isn't locked down, the FDA will be uncomfortable approving without the CVOT.". -Lipid levels should be checked within 8 to 12 weeks of treatment initiation. A re-engineered adenovirus prolonged survival in mouse models of metastatic lung cancer and cleared tumors in about 35% of the animals. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. It is not known if bempedoic acid can lower the risk of complications related to high cholesterol (such as heart problems, heart attack , stroke, or death). Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative. Participants were randomized 2:1 versus placebo, which saw two total deaths, or 0.3%, with one being labeled as CV-related following adjudication by an independent committee. Zetia, atorvastatin, simvastatin, rosuvastatin, Lipitor, Crestor. kidney disease (or if you are on dialysis); Bempedoic acid may harm an unborn baby. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use. RELATED: Esperion’s LDL drug flies through phase 2 as add-on treatment. also assessed the efficacy and safety of bempedoic acid in statin-intolerant patients with hypercholesterolemia over a period of 24 weeks. With daily, oral bempedoic acid, Esperion hopes to offer a cheaper alternative, at about $4,000 annually, to lowering LDL in combination with a statin, compared to PCSK9 inhibitor infusions from Amgen and Regeneron with list prices that can reach $14,000 a year. Polyphor is developing an inhaled version of murepavadin, which targets Pseudomonas aeruginosa infections, but is currently given intravenously. The company characterized the adverse events as unrelated to treatment, with some linked to lung cancer, in a high-risk population of mostly current and former smokers.