"Silent" MIs Outweigh "Scary" Bleeds, FDA Concludes In Effient Review
FDA's approval of Lilly/Daiichi Sankyo's antiplatelet agent Effient (prasugrel) reflects the review team’s willingness to look past the increased risk of bleeding – a dramatic and viscerally alarming adverse event, though understandable due to the medical setting – to see the less immediately apparent benefit of a reduction in a type of cardiac event that includes so-called "silent MIs" that have no visible clinical presentation.
More from Archive
More from Pink Sheet
Lowell Zeta, a senior counselor at the FDA from 2020 to 2021, returns as deputy commissioner for strategic initiatives. The agency also names a new acting CIO and acting CVM director, but OGD's Ted Sherwood and OPDP's Catherine Gray retired.
The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.
Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.