ICN’s Ribavirin Gets Key FDA Panel Go-Ahead

A key government panel recommended Monday that ICN Pharmaceuticals Inc.’s drug ribavirin be approved in combination with another drug for treating patients who suffer relapses of the severe liver ailment hepatitis C.

If the Food and Drug Administration accepts the recommendation of its advisory committee--as it usually does--ICN will clear a major hurdle in its lengthy effort to persuade regulators to approve the drug for multiple uses.

FDA approval could also spell hope in battling a sometimes fatal disease that has afflicted an estimated 4 million Americans, most of whom haven’t been diagnosed.

Analysts expect that within two months the agency will approve ribavirin as a therapy in combination with Schering-Plough Corp.’s drug Intron A as a treatment for patients suffering relapses. The move would give ICN a powerful financial boost, they say.

The panel Monday voted 8-0 to recommend that the application be approved, triggering gains in both company’s stocks. ICN’s shares moved up $2 to $51.13, while Schering-Plough rose $1.69 to $81.81 a share.

Schering-Plough’s drug has been approved as a treatment for hepatitis. ICN’s product is sold under the brand name Virazole to treat severe respiratory infections in hospitalized children.

Together, the two drugs provide a significant benefit for patients who have few successful treatment options after suffering relapses, panel members said.

In tests on hundreds of hepatitis patients who suffered relapses, there was a tenfold increase in those with no viral levels after taking the drugs alpha interferon and ribavirin.

Analysts say the panel’s vote Monday is a move in the right direction for ICN, a company that has struggled to persuade regulators to approve wider uses beyond treating severe respiratory infection in hospitalized infants.