FDA Has Positive Outlook on Prescription Drug Brilinta
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The prescription drug, Brilinta looks set to receive a recommendation for approval by the FDA, according to recent documents released on Wednesday as part of a US regulatory panel meeting.
The papers, which were published on the FDA website, show that these pharmaceutical drugs seems to be an effective medication, based on data gathered from a 18,624-patient study. The trial was part of its Phase III head-to-head investigation which trialled the drug with aspirin and the bloodthinner Plavix (clopidogrel). There was a marked difference in the effectiveness of the drug prescription when taken by US and on-US participants.
AstraZeneca, the company behind Brilinta, believes that the difference in effectiveness can be related to varying levels in the doses of commercial aspirin within the USA (although this has been met with some scepticism among reviewers). Despite the findings, the FDA’s Office of Clinical Pharmacology has recommended that the prescription drug Brilinta be approved, under the condition that the disproportionate findings in non-US and US patients be further investigated.
Who Is This Drug Aimed At?
Brilinta is the first in a new class of drugs - cyclo-pentyl-triazolo-pyrimidines (CPTPs). The prescription drug Brilinta promises to reduce cardiovascular events (for example, stroke and heart attack) for up to a year, specifically in patients suffering from Acute Coronary Syndrome. Whether the FDA will actually approve the prescription medicine remains to be seen, however the initial findings certainly seem to suggest that an FDA approval is just around the corner.
