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Hayes, Inc. Technology Prognosis Team Tracks First-of-a-Kind Technologies
Date:5/7/2010

Healthcare professionals informed of every milestone leading to regulatory approval for Alair® and Provenge®

Lansdale, PA (PRWEB) -- Hayes Inc., the nation’s leading independent health technology research and consulting company, announces the release of two reports on first-of-a-kind technologies just approved by the Food and Drug Administration (FDA)—the Alair® Bronchial Thermoplasty System for medically refractory asthma, and the Provenge® prostate cancer vaccine for men with metastatic hormone-refractory disease. Hayes’ horizon scanning experts identified these emerging technologies more than 7 years ago as potential new options to address unmet treatment needs. Technology Prognosis, Hayes’ continuously updated horizon scanning service, has kept clients informed of every milestone leading to regulatory approval.

The Alair system for bronchial thermoplasty has potential to improve symptom control in adults with severe, medically refractory asthma, but the device and procedure have been evaluated in relatively few patients. The FDA based its approval on data from a clinical trial of 297 patients with severe and persistent asthma. The trial showed a reduction of severe asthma attacks with use of the Alair system. The FDA is requiring a 5-year postmarket study of the device to research its long-term safety and effectiveness.

Provenge is a vaccine given intravenously for the treatment of metastatic androgen-independent prostate cancer (AIPC), a grave condition with few treatment options. It does not prevent prostate cancer, and it is being evaluated only in patients already diagnosed with this disease. The vaccine appears to offer a modest but significant overall survival benefit in this patient subset but does not significantly delay the progression of the disease. Access to the vaccine may be limited initially by manufacturing capacity
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