Drug Criteria & Outcomes
FDA recently announced these approvals: FDA approved Medtronic's Endeavor® Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries. FDA said the Endeavor is the first drug-eluting stent approved since 2004 and the first since FDA convened its Circulatory System Devices Panel in 2006 to discuss evidence of the rare risk of blood clots occurring in patients who receive drug-eluting stents.
FDA said slow release of zotarolimus over time prevents the artery from re-narrowing when tissue begins to form.
Medtronic provided data from seven clinical trials in its marketing application. FDA said studies showed that the Endeavor significantly reduced the number of major coronary events, such as heart attack, cardiac death, and repeat procedures to reopen the artery, compared to a bare-metal stent. It also cut the resteonosis rate by about half.
Imaging studies on a subset of patients indicated that Endeavor's restenosis rate was higher than what is seen in drug-eluting stents already on the market. But it had a similar number of coronary events when compared to one of these stents. The number of adverse events experienced by patients implanted with the Endeavor stent was similar to those that occurred in patients implanted with bare-metal stents and existing drug-eluting stents.
The Endeavor stent thrombosis rate was 0.4% at one year and 0.5% at two years, a rate similar to that for bare-metal stents. To reduce such clotting risk, patients receiving an Endeavor stent will need to take blood-thinning medication for at least six months after implantation and should consider continuing the regimen for 12 months if they are not at an increased risk of bleeding complications.
• Teva Pharmaceuticals' generic version of Fosamax® (alendronate sodium tablets) was approved by FDA for treating osteoporosis. Teva will manufacture alendronate sodium tablets in three once-daily dosing strengths (5 mg, 10 mg, and 40 mg) and two once-weekly dosing strengths of 35 mg and 70 mg.
In addition, Barr Laboratories was approved to manufacture a 70 mg once-weekly dose of the drug.
FDA recently announced these approvals: FDA approved Medtronic's Endeavor® Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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