Schering-Plough receives approval for therapy

Schering-Plough announced today it has received marketing approval for its Pegintron and Rebetol combination therapy.

The drug is for use in previously untreated patients three years of age and older, who have chronic hepatitis C.

Based on the results of a clinical trial, it is the first and only Pegintron in combination with Rebetol therapy to be approved, the company said.

The study involved 107 previously untreated patients aged three to 17 years old who have chronic hepatitis C and compensated liver disease.

Robert Spiegel, chief medical officer of Schering-Plough Research Institute, said the approval of the combination therapy means physicians now have access to the “current standard of care” for the disease.

He added: “This approval further underscores Schering-Plough’s leadership and long-term commitment to developing new treatment options and innovative therapies to meet the needs of patients with hepatitis C.”

The recommended oral dose of Pegintron is based on body surface area and is 60 mcg/m2/week subcutaneously in combination with 15 mg/kg/day of Rebetol, based on body weight.

Patients that have the genotype 1 strain of hepatitis C are recommended to stay on the medication for 48 weeks, while genotype 2 or 3 subjects should stay on it for 24 weeks.

Based in Kenilworth, US, Schering-Plough employs 55,000 people around the world, with business operations in more than 140 countries.