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UPDATE 1-Schering-Plough hepatitis combo gets OK EU opinion

Mon Sep 24, 2007 9:38am EDT

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BOSTON, Sept. 24 (Reuters) - Advisers to the European Commission have recommended approval of a combination hepatitis C therapy tested by Schering-Plough Corp. SGP.N to re-treat patients who have failed a previous round of therapy, the company said on Monday.

The Kenilworth, New Jersey-based drugmaker said the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of the combination of Schering-Plough's Peg-Intron and Rebetol, a standard treatment also known as ribavirin.

The opinion was based on results of a continuing clinical study involving 1,336 patients who failed previous treatments.

Interferon therapy is designed to boost the immune system. Schering-Plough's version, Peg-Intron, competes with Roche Holding AG's (ROG.VX) Pegasys. These drugs are the mainstay of hepatitis C treatment.

Peg-Intron is approved in the United States as a single agent treatment and for use in combination with Rebetol.

Schering-Plough said it tested the combination therapy in patients who had failed other interferon-based therapies. If approved the company said the combination would be the only available hepatitis C treatment in Europe indicated for prior treatment failures. (Reporting by Toni Clarke)



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