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CORDARONE APPROVAL BY FDA GIVES IVES A DOWRY FOR ORGANIZATIONAL MARRIAGE WITH WYETH; ANTI-ARRHYTHMIC CLEARED FOR USE IN LIFE-THREATENING SITUATIONS

Executive Summary

Ives' dowry for its marriage with Wyeth is the anti-arrhythmic agent Cordarone (amiodarone HCl), which was approved by FDA on Dec. 27. Cordarone is a 1C drug (new molecular entity with little therapeutic gain) for use to treat certain "life-threatening recurrent ventricular arrhythmias, when these have not responded to documented adequate doses of available anti-arrhythmics or when alternative agents could not be tolerated," FDA said in a press release accompanying approval of the drug. Cordarone will be marketed by Wyeth, which is absorbing Ives Labs under a reorganization of the two American Home Products Rx drug units which became effective on Jan. 1. lves was the original sponsor of the drug. By folding Ives into Wyeth, American Home Products is consolidating two separate sales forces into one 1,250 man unit. The combined unit will allow Wyeth to establish sales segments specializing in certain product areas such as cardiovasculars, psychopharmacologic agents and oral contraceptives. The merged units will be headed by Wyeth Chairman Richard Bogash and President Bernard Canavan. Ives President Thomas Cavanaugh becomes a senior VP at Wyeth. Cordarone will be an immediate project for the newly combined sales force's cardiovascular specialists because the drug is intended for use by cardiologists. Labeling includes the bold print instruction that, "because of the unique pharmacokinetic properties, difficult dosing schedule, and severity of the side effects if patients are improperly monitored, Cordarone should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias who are thoroughly familiar with the risks and benefits of Cordarone therapy, and who have access to laboratory facilities capable of adequately monitoring the effectiveness and side effects of treatment." An FDA "Talk Paper" described Cordarone as a very difficult drug to use. "Its effect is greatly delayed, by one to three weeks as a rule. . . If for any reason the drug must be stopped or decreased, weeks or even months may elapse before the abnormal rhythm reoccurs and the time of return is unpredictable. During this period these patients are a major management problem and again may need prolonged hospitalization. Amiodarone also affects the blood levels of many other drugs, including other anti-arrhythmics, again making management complicated." FDA approved labeling states that "Cordarone is intended for use only in patients with the life-threatening arrhythmias because its use is accompanied by substantial toxicity." Potentially lethal lung damage (interstitial pneumonitis/alveolitis) is the most serious side effect, occurring "at rates as high as 10-15% in some series of patients with ventricular arrhythmias given doses around 400 mg/day and fatal about 10% of the time." Liver injury, coordination difficulties and gastrointestinal and thyroid problems are other side effects. In his approval letter, FDA Office of Drug Research and Review Director Robert Temple, MD, instructed the company to pursue studies that would establish the safety and efficacy of Cordarone for other uses. He recommended that "repeat teratology (Segment II) studies be conducted with amiodarone . . . in order to be in a position to defend broadening of indications." Temple added that "approved labeling does not allow claims related to atrial arrhythmias but the potential usefulness of amiodarone in these arrhythmias is widely recognized. Controlled clinical trials in patients with atrial arrhythmias need to be conducted."

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