“Superiority, not to a placebo, but to an active drug ..., prasugrel's efficacy seems beyond question," said United States Food and Drug Administration (FDA) staff reviewers, indicating approval.
FDA’s advisory panel revealed the information online through a 357-page FDA document. It said that despite many side effects, blood-clot preventer prasugrel reduces the risk of heart attacks in the patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention (PCI).
The report has been released beforehand, while FDA advisory panel is scheduled to meet on Tuesday to discuss whether to approve prasugrel and under what conditions.
The agency will also ask from outside cardiology
define experts to evaluate prasugrel’s risks and benefits. After discussing the issue, the advisory panel will give its final recommendation to the FDA to consider it during the approval process.
The document also revealed that the researchers compared Indianapolis-based Lilly’s prasugrel with leading blood thinner Plavix made by Bristol-Myers Squibb and Sanofi-Aventis in the key study.
They found that prasugrel drug was better than Plavix in reducing the risks of heart attacks but also caused some internal bleeding risks. They also noted that the patients who received prasugrel were more likely to develop cancerdefine than those who took Plavix, though it was not clear that only prasugrel raised the risk of cancer.
“Nevertheless, risk of cancer is always of great interest to practitioners and patients, and cannot be ignored; A precaution seems appropriate for labeling at this time…,” the document stated.
Eli Lilly Vice President Dr. Anthony Ware said in an interview, “We feel like we've investigated this issue very carefully, and there's no scientific evidence that prasugrel causes new cancer or makes an existing cancer worse."
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