To: Barron Von Hymen who wrote (6863 ) 1/29/1999 8:23:00 AM From: BigKNY3 Read Replies (4) | Respond to of 9523
Heart Drug by Pfizer Gets Boost as Panel Backs Its Approval 01/29/99 The Wall Street Journal WASHINGTON -- Government advisers recommended approval of Pfizer Inc.'s new heart-rhythm drug Tikosyn, paving the way for one of the first new heart-rhythm drugs in years. Separately, Pfizer said its board will vote on a proposed 3-for-1 common stock split on April 22, immediately after the company's annual meeting. In a boost for Pfizer, a panel of scientific advisers recommended that the U.S. Food and Drug Administration approve Tikosyn for patients with atrial fibrillation. Atrial fibrillation, the most common abnormal heart rhythm, occurs when the heart's upper chambers quiver instead of beat properly. This is a major risk factor for stroke and has related symptoms such as light-headedness and fatigue. The disorder affects more than 10 million people world-wide. But development of new drugs for the disorder has been difficult, as many older drugs have run into problems with life-threatening side effects. During the daylong meeting, Pfizer representatives presented data from several Tikosyn trials of more than 8,500 patients. Of the patients treated with Tikosyn, 60% to 70% were able to maintain a normal heartbeat rhythm for a year, said doctors presenting the data for Pfizer. The company also said there was no difference in noncardiac adverse events in patients who received Tikosyn, compared with those given an inactive placebo. The FDA usually heeds the advice of its expert advisory panels when deciding whether to approve products for sale in the U.S., although it isn't required to.