FDA expands Brilinta approval for long-term use in patients with heart attack history
FDA has expanded approval for ticagrelor (Brilinta, AstraZeneca) to include long-term use in patients with a history of heart attack.
FDA has expanded approval for ticagrelor (Brilinta, AstraZeneca) to include long-term use in patients with a history of heart attack.
Brilinta is an oral antiplatelet medication that was originally approved by the FDA in July 2011 and is the first and only oral antiplatelet to demonstrate superior reductions in cardiovascular death compared to clopidogrel. In the management of ACS, the recommended maintenance dose of Brilinta is 90 mg twice daily during the first year after the cardiovascular (CV) event. With the expanded approval, patients with a history of heart attack can now be treated with 60 mg twice daily beyond the first year.
Related:FDA grants priority review to expand use of Brillinta
FDA's approval is based on a clinical study which included more than 21,000 patients and demonstrated that both the 60-mg and 90-mg study doses of Brilinta plus low-dose aspirin significantly reduced the rate of atherothrombic events compared to placebo.
According to a company statement from AstraZeneca: “Recent research has shown that 1 in 5 patients will have a further heart attack, stroke or CV death in the subsequent 3 years following a heart attack, even if patients were event free after 12 months. Patients with a history of a heart attack remain at high and persistent risk for recurrent CV events.”
For patients who have been prescribed this drug, the drug manufacturer offers the Brilinta Patient Support Service (BPSS) tool that provides resources and support to help patients and caregivers from hospital discharge throughout the ACS treatment journey.
The new 60-mg tablet will be available in pharmacies by the end of September.
Read next: [BLOG]: The acute coronary syndrome pipeline
FDA Approves Subcutaneous Tecentriq to Treat Multiple Cancers
September 13th 2024Tecentriq Hybreza can be administered over seven minutes, compared with 30 to 60 minutes for IV infusion of Tecentriq. There is no word yet on when Tecentriq Hybreza will be available or what the price will be.
Read More
FDA Warns of Liver Injury with Veozah for Hot Flashes
September 12th 2024The FDA has identified a probable case of serious drug induced liver injury that occurred in a woman in the United States who had received Veozah. The agency is requiring additional liver blood testing after starting therapy.
Read More
