FDA ADVISORY COMMITTEE ENDORSES MYOSCINT WOULD BE FIRST MAB-BASED IMAGING AGENT IN THE UNITED STATES
FDA ADVISORY COMMITTEE ENDORSES MYOSCINT
WOULD BE FIRST MAB-BASED IMAGING AGENT IN THE UNITED STATES
BETHESDA, Md., Nov. 26 /PRNewswire/ -- The Food and Drug Administration's Biological Response Modifiers Advisory Committee today unanimously recommended that Myoscint(R) (imciromab pentetate) be cleared for marketing for the detection of the presence, location, and extent of myocardial necrosis in the setting of acute ischemic heart disease.
Myoscint is a radiolabeled imaging agent that uses a monoclonal antibody fragment to seek out and bind to dead heart tissue.
Myoscint is the first monoclonal antibody-based imaging agent to receive such a recommendation in the United States. The FDA will now consider the committee's advice.
"This decision by the committee reinforces the potential contribution of monoclonal antibodies to human health care," said James E. Wavle, Jr., Centocor's president and chief executive officer. "We are looking forward to working with the FDA on the final approval of Myoscint so that it can be available as another tool to help U.S. physicians to diagnose heart attacks and better discern the degree of injury to the heart."
Myocardial necrosis, or heart-tissue death, typically occurs during a heart attack. About 1.5 million people in the United States suffer heart attacks every year; about 1 million survive, many of whom can benefit from continuing medical care.
Myoscint is a murine monoclonal antibody Fab fragment bound to DTPA (diethylenetriaminepentaacetic acid) that is radiolabeled with indium-111 for cardiac imaging performed with a nuclear medicine gamma camera employing either planar or tomographic techniques. Myoscint binds with high affinity and specificity to myosin, a protein exposed in necrotic myocardial cells. Trials of Myoscint involving more than 1,000 patients have been conducted in the United States, Canada, and Europe.
Myoscint is currently available in several European nations, where Centocor markets it directly. McNeil Pharmaceutical, an affiliate of Johnson & Johnson, will market Myoscint in the United States.
Centocor, Inc. (NASDAQ: CNTO), based in Malvern, Pa., develops, manufactures and markets diagnostic and therapeutic products for human health care. The company's products are based on monoclonal antibody technology and are primarily intended for use in infectious, cardiovascular, and autoimmune diseases and cancer.
/CONTACT: Charles C. Cabot III, 215-889-4456, Richard M. Koenig, 215-651-6122, or Thomas A. Pearson, 215-648-3975, all of Centocor/
(CNTO) CO: Centocor, Inc. ST: Pennsylvania IN: MTC SU:
MK -- PH036 -- 7380 11/26/91 14:16 EST