Schering-Plough announces EU approval for Pegintron and Rebetol

Schering-Plough has announced today that the European commission has approved its Pegintron and Rebetol combination therapy for retreating hepatitis C patients who have previously failed pegylated or non-pegylated interferon therapy.

Approval has been given for a 48-week combination of once-weekly Pegintron (peginterferon alfa- 1.5mcg/kg) and daily Rebetol (ribavirin 800 – 1,400mg) in patients with chronic hepatitis C.

The combination is the first and only pegylated interferon combination therapy that has been approved in the European Union for re-treating both hepatitis C relapsers and nonresponders.

Nadine Piorkowsky, president of the European Liver Patient Association, indicated that the European commission’s decision meant that many hepatitis C patients will now have a second chance at therapy.

“These patients want to eradicate the virus and now can determine after 12 weeks of retreatment with Pegintron combination therapy whether they are likely to go on to achieve a sustained response with a 48-week course of therapy.”

The approval was informed by positive results from an ongoing non-comparative clinical study in which patients with moderate to severe fibrosis or cirrhosis were re-treated with the Pegintron-Rebetol combination after previously failing treatment with combination alpha interferon/ribavirin therapy

Schering-Plough announced this week that an estimated one million patients have now been treated with its anti-tumour necrosis factor-alpha therapy Remicade (infliximab).