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European approval for shortened course of Roche drug

26 Jun 2008

Regulatory Affairs

Roche's hepatitis C drug Pegasys has been approved by the European Commission for a shortened course of treatment with certain patients, the company has said.

The drug is approved for use with the medicine Copegus as a 16-week course in patients with particular strains of chronic hepatitis C who have low virus levels before treatment and show a rapid virological response, Roche reported.

It adds that the development is "good news" for eligible patients, as previously they received 24 weeks of the treatment regardless of their virus levels and response to the therapy.

William M Burns, chief executive officer of Roche Pharmaceuticals Division, commented: "Response-guided therapy in hepatitis C is an excellent example of how Roche is uniquely positioned to individualise healthcare."

He added that the approval shows "the value of using diagnostic tools to determine an individual treatment regimen", while expressing the hope that more eligible patients will come forward for treatment.

Meanwhile, Roche announced earlier this week that its ownership stake in Chugai is to increase from 50.1 per cent to 59.9 per cent following the successful completion of its tender offer.


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