Schering Plough receives EU approval for hepatitis C therapy

Schering Plough’s Pegintron and Rebetol combination hepatitis C therapy has received a positive opinion from the EU’s Committee for Medicinal Products for Human Use (CHMP).

CHMP, part of the European Medicines Agency (EMEA) recommended the approval of combination therapy with Pegintron and Rebetol after observing medical data from a clinical trial of 1,336 patients with moderate to severe fibrosis or cirrhosis who received the combination therapy after failing previous forms of treatment.

After 12 weeks of treatment, 57 per cent achieved sustained virological response under a further 48-week course of therapy, while the virus was also deemed undetectable among 23 per cent of this subgroup at 24 weeks post-treatment.

While still waiting for marketing approval from the European commission, the combination therapy would be the only hepatitis C drug in the EU available for patients with previous treatment failures.

Company chief medical officer and senior vice president Robert J Speigel stated his belief that the Pegintron combination therapy would help meet the need for of the “hard to treat patient population.”

Schering-Plough researches across a number of areas, which include cardiovascular and metabolic diseases, as well as central nervous system disorders.