FDA Panel Urges More Tests on Angina Drug

CV Therapeutics Inc. needs to conduct more studies on its Ranexa drug before it can be used to treat chest pain, a Food and Drug Administration advisory panel said.

The Palo Alto biotechnology company is seeking approval to sell Ranexa for treating angina, the pain caused when the heart muscle is deprived of oxygen.

The panel agreed with the FDA’s staff, which Monday recommended more tests because of concerns over how Ranexa affects heart rhythms. CV’s shares, which plunged 27% on Monday, didn’t trade Tuesday.

Approval of Ranexa would give the 13-year-old biotechnology company its first product to sell. Analysts, who once predicted annual sales of more than $200 million, say the company might have to conduct several years of research to address the FDA’s concerns.

From Bloomberg News