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The European Medicines Agency, or EMA, has awarded Big Pharma Roche (NASDAQOTH: RHHBY ) expanded approval for its antiviral Pegasys, alongside ribavirin, in treating chronic hepatitis C virus, or HCV. The EMA's expanded approval will now allow Roche to treat HCV-positive children aged 5 and older with the drug who have not yet begun treatment, according to a statement from the company.
Roche first won European approval for Pegasys in treating adults with chronic HCV more than a decade ago; regulators in China and the U.S. have approved it as well. Around 65,000 European children suffer from chronic HCV; while Roche states that many sufferers of the disease show few if any symptoms, it is progressive and can afflict patients with life-threatening ailments such as liver damage.
Dr. Hal Barron, Roche's chief medical officer and global product development Head talked about the new indication’s benefit for children with the disease, saying in the release: “Hepatitis C can ultimately lead to the development of advanced liver disease if left untreated. This approval provides doctors and parents of children as young as five with a treatment combination for this infection.”