FDA Approves Abbott's XIENCE(TM) V Drug Eluting Stent

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 03 Jul 2008 - 1:00 PDT

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Abbott announced that the U.S. Food and Drug Administration (FDA) approved the XIENCE(TM) V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. XIENCE V is the only drug eluting stent to have demonstrated superiority over Boston Scientific's TAXUS(R) paclitaxel-eluting coronary stent system in two randomized head-to-head clinical trials. XIENCE V will be launched in the United States immediately.

"XIENCE V represents an important treatment advance for the estimated 13 million people in the United States suffering from coronary artery disease, and we believe XIENCE V will quickly become the new standard for drug eluting stents given its outstanding clinical results," said John M. Capek, Ph.D., executive vice president, Medical Devices, Abbott. "Physicians in the United States have been waiting for years to treat their patients with a technology that delivers on the promise of drug eluting stents through both ease of use and excellent clinical performance, and XIENCE V is that technology."

The XIENCE V drug coated stent is used to treat coronary artery disease by propping open a narrowed or blocked artery and releasing the drug, everolimus, in a controlled manner to prevent the artery from becoming blocked again following a stent procedure. Coronary artery disease occurs when plaque build- up narrows the arteries and reduces blood flow to the heart, which can lead to chest pain or a heart attack.

"XIENCE V was designed to improve safety and efficacy compared to earlier generation stents. The long-term clinical data from two studies performed in both the United States and Europe have now confirmed that XIENCE V is a true next-generation drug eluting stent with clinically important benefits for patients," said Gregg W. Stone, M.D., Columbia University Medical Center; chairman, Cardiovascular Research Foundation, New York; and principal investigator of the SPIRIT III U.S. pivotal clinical trial for XIENCE V.

Clinical Data Supporting XIENCE V

The robust clinical program for XIENCE V includes long-term data from a total of 1,362 patients enrolled in the SPIRIT FIRST, SPIRIT II and SPIRIT III trials, as well as continued access and post-approval programs that will enroll more than 14,000 XIENCE V patients.

The FDA approved XIENCE V based, in large part, on superior results from the 1,002 patient SPIRIT III U.S. pivotal clinical trial, in which XIENCE V demonstrated statistical superiority to TAXUS on the study's primary endpoint of in-segment late loss (vessel renarrowing) at eight months, with a statistically significant 50 percent reduction (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS). XIENCE V also demonstrated statistical non-inferiority to TAXUS in the co-primary endpoint of target vessel failure (TVF, cardiac events related to the stented vessel) at nine months, with an observed 20 percent reduction (7.2 percent for XIENCE V vs. 9.0 percent for TAXUS). TVF is a composite clinical measure of safety and efficacy outcomes defined as cardiac death, heart attack (myocardial infarction or MI) or target vessel revascularization (TVR).

In May 2008, Abbott presented two-year data from the SPIRIT III trial demonstrating that XIENCE V continues to deliver positive clinical benefits for patients. At two years, the XIENCE V demonstrated the following key results:

-- A 45 percent reduction in the risk of major adverse cardiac events (MACE) compared to TAXUS (7.3 percent for XIENCE V vs. 12.8 percent for TAXUS, p-value=0.004)*. MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (MI) or ischemia-driven target lesion revascularization (TLR, repeat procedures driven by lack of blood supply).

-- A 32 percent reduction in the risk of TVF compared to TAXUS (10.7 percent for XIENCE V vs. 15.4 percent for TAXUS, p-value=0.04).

-- Low rates of stent thrombosis between one and two years, defined as very late stent thrombosis, per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis (0.3 percent for XIENCE V and 1.0 percent for TAXUS) and per the SPIRIT III protocol (0.2 percent for XIENCE V and 1.0 percent for TAXUS). The ARC definition of late stent thrombosis was developed to eliminate variability in the definitions across various drug eluting stent trials.

"Today's approval of XIENCE V is a reflection of Abbott's ongoing commitment to bring innovation-driven, leading-edge medical technologies to the people who need them," added Capek. "With one of the largest, most seasoned vascular sales forces in the United States and with the ability to supply more than half the worldwide market, we will begin shipping units of XIENCE V immediately to meet physician demand for this much awaited, next- generation technology."

More About XIENCE V

XIENCE V is built upon Abbott's market-leading bare metal stent, the MULTI-LINK VISION(R) Coronary Stent System. The VISION platform is designed to facilitate ease of delivery, making it easier for physicians to maneuver the stent and treat the diseased portion of the artery.

The XIENCE V drug coated stent will be available on both over-the-wire (OTW) and rapid exchange (RX) delivery systems. Rapid exchange is the most widely used type of delivery system because it provides physicians additional flexibility to work as single operators during stent procedures.

XIENCE V was launched in Europe and other international markets in October 2006. XIENCE V is an investigational device in Japan and is currently under review for approval by Japan's Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA).

Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS(TM) Everolimus-Eluting Coronary Stent System. PROMUS is designed and manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies.

Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its antiproliferative properties.

Additional information about XIENCE V, including important safety and effectiveness information, is available online at http://www.xiencev.com.

About Abbott Vascular

Abbott Vascular, a division of Abbott, is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.

Event rates are based on Kaplan-Meier estimates; p-values are for descriptive purposes only.

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