Gensia Inc. announced Wednesday that it plans to fileregulatory submissions in the U.S., Canada and Western Europeon its Genesa system for diagnosing coronary artery disease.
The San Diego company intends to file a new drug application(NDA) with the U.S. FDA in the fourth quarter, followed by amarketing authorization application (MAA) to the MedicinalControl Agency in the United Kingdom by the end of the year.
And in the first quarter of 1994, Gensia (NASDAQ:GNSA) plansto submit MAAs to each of the 12 members of the EuropeanCommunity and to the five countries that are members of theEuropean Free Trade Association, as well as complete a newdrug submission (NDS) in Canada.
The Genesa system combines the drug arbutamine and acomputer-controlled, closed-loop drug delivery systemdesigned to pharmacologically stress the heart. It monitorsheart rate and blood pressure, and controls the rate of drugdelivery. In conjunction with electrocardiography (ECG),echocardiography and radionuclide imaging, Genesa is meant tobe used as an aid in diagnosing coronary artery disease.
Gensia's confidence in its product stems from an analysis of thesafety and efficacy results of international multicenter PhaseIII clinical trials. "The results from the Phase III clinicalprogram were consistent with those in Phase II clinical trialsusing ECG and echocardiography in patients with coronaryartery disease, said David Hale, president and chief executiveofficer of Gensia. The device also performed well in the PhaseIII clinical trials."
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