FDA May Rule Today on Novartis’ Zometa Drug

Novartis, Europe’s third-biggest drug maker, needs to win U.S. approval for the experimental medicine Zometa to start turning around a 18% drop in shares this year, analysts and investors said.

The Food and Drug Administration may rule today on the drug, designed to treat a life-threatening condition in which too much calcium enters the bloodstream. The U.S. agency has been reviewing additional data after last year deeming Zometa “approvable.”

Zometa is the last of five potential top-selling medications that the Basel, Switzerland-based company had slated for introduction this year. Two of the treatments won approval, while the other two were rejected, causing Novartis’ shares to slide.

Novartis designed Zometa to replace its older Aredia medicine, which faces competition from cheaper generic versions. Studies have found that Zometa can help more patients and takes less time to infuse than Aredia, which had sales of $660 million last year.

The FDA has rejected two of Novartis’ medicines this year, an irritable bowel syndrome treatment known as Zelnorm and the asthma drug Xolair.

The company’s American depositary receipts have lost 20% this year. They closed Friday up 13 cents at $35.25 on the New York Stock Exchange.