SmithKline Beecham Wins Priority FDA Review for Diabetes Drug
Bloomberg News January 21, 1999, 10:11 a.m. ET
SmithKline Beecham Wins Priority FDA Review for Diabetes Drug
Washington, Jan. 21 (Bloomberg) -- SmithKline Beecham Plc, Europe's third largest drugmaker, said U.S. regulators have designated the company's new diabetes medicine a ''priority'' drug, which means it could be cleared for sale by the end of May.
SmithKline filed for U.S. Food and Drug Administration approval of the drug, known as Avandia, in November. It's designed to treat Type 2 diabetes, the most common form of the disease.
Avandia is a member of a class of drugs that include Warner- Lambert Co.'s Rezulin, a hot seller which has been plagued recently by reports of liver problems and patient deaths. If SmithKline's Avandia can prove safer, it could generate sales topping $1 billion, analysts have said.
SmithKline's American depositary receipts rose 1 5/16 to 73 5/16 in early trading. In London, shares rose 7.5 pence to 888.
Diabetes is a chronic illness characterized by an inability to make or to properly use insulin, a hormone that helps process blood sugar. The disease affects an estimated 16 million people in the U.S., though many patients don't know they have it.
Both Avandia and Rezulin work by increasing the body's sensitivity to insulin, thereby helping the body control levels of blood sugar. If diabetics fail to properly control blood sugar, they're at risk for problems including stroke, blindness and even death.
--Kristin Jensen in the Washington newsroom (202) 624-1843 /mfr |