Pfizer Takes Heart Drug Tikosyn To FDA Panel Thursday
By Otesa Middleton
WASHINGTON (Dow Jones)--Pfizer Inc. (PFE) seeks support from a federal panel Thursday for its heart drug Tikosyn.
The U.S. Food and Drug Administration will ultimately decide whether the pill, designed to treat atrial fibrillation, can be sold in the U.S. The agency usually approves products backed by its outside, expert panels.
The drug, generically called dofetilide, is designed to keep the heart's normal rhythm and reduce related symptoms such as shortness of breath, lightheadedness and fatigue according to the company.
The company will present the panel with study data from two trials involving more than 3,000 patients.
In one Tikosyn study, the drug helped two-thirds of patients maintain a normal heart rhythm for a year, compared to 25% of patients given an inactive placebo.
Another study showed Tikosyn worked safely in patients who recently had a heart attack.
Le Anne Zhao, an analyst who follows Pfizer for Southeast Research Partners, said she believes the panel will recommend Tikosyn for approval.
"There are very few products on the market," Zhao said.
Procter & Gamble Co. (PG) filed a new drug application with the FDA in December for its antiarrhythmic drug, with the chemical name azimilide.
Tikosyn's sales potential will depend on what its label will say, Zhao said.
"About 2.2 million Americans have unstable-heartbeat disease," Zhao said.
If approved, Tikosyn could have $100 million in sales for 1999, with sales doubling in 2000, she projects.
Atrial fibrillation, the most common abnormal heart rhythm, describes a condition in which the heart's upper chambers quiver instead of beating properly. This is a major risk factor for stroke and can lead to other complications. Atrial fibrillation affects more 10 million people worldwide, and more than 5% of people over 70 years ol
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