Through centuries of misinterpretation, this Shakespearean expression has come to mean being left in limbo, which is exactly the state in which the cardiovascular industry was left when the FDA decided to further postpone its decision on prasugrel.
Three months ago, the agency sets its action date for last Friday, and yet, on decision day, chose not to act. However, Dr. Victor L. Serebruany, who was a principal investigator on one of the drug’s first trials, told Cardiovascular Business News that prasugrel may have passed through the regulatory process with more ease if it were not for the high dosing maintenance. He suggested this also led to the instances of higher bleeding rates compared to clopidogrel during the pre-market clinical trials.
Despite these considerations, the FDA has not set a new timeline for its decision on the much-anticipated antiplatelet drug, which means the cardiology community, in the meantime, will have to wait with bated breath.
The FDA did, however, approve Boston Scientific’s Taxus Express2 Atom stent system for vessels as small as 2.25 millimeters in diameter, as well as for the treatment of in-stent restenosis in bare-metal stents (BMS). The company is hoping that this approval could also indicate an earlier lift on the two-year ban for its Taxus Liberte drug-eluting stent (DES). It believes the agency is beginning to loosen a corporate warning letter imposed in 2006 over manufacturing violations.
Boston Scientific might need those additional sales since a Delaware district court awarded Johnson & Johnson damages totaling $702.7 million from Boston Scientific and $521 million from Medtronic, in a case involving a stent patent owned by J &J.
On the clinical side of the stents, Dr. Laura Mauri’s large MASS Registry has continued to churn out positive results for DES compared to BMS, showing lower rates of mortality and revascularization at two-years.
Over the next few weeks, the interventional specialty will be prominently featured, particularly through the lens of the upcoming Transcatheter Cardiovascular Therapeutics (TCT) symposium. Cardiovascular Business News will roll out its news coverage next week with conference previews on Tuesday and Wednesday; and an interview with Dr. Gregg W. Stone, director of TCT, that will appear in Thursday’s newsletter.
Please join us today at 2 p.m. for a free video webcast and live Q &A with clinical, administrative and IT leaders answering questions regarding the implementation of a cardiology PACS and cardiovascular information system (CVIS). Industry experts will share their in-depth knowledge and personal experiences into the processes and strategies utilized within each of their own facilities.
On these topics, or any others, please feel free to contact me.
Justine Cadet, News Editor