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FDA Danışma Kurulu, Simeprevir İçin Hepatit C Tedavisinde Kullanılmak Üzere Onay Verilmesini Önerdi

(Reuters) – An advisory committee of the U.S. Food and Drug Administration voted unanimously to approve Johnson & Johnson’s hepatitis C drug, J&J said on Thursday.

The panel voted 19-0 in favor of the drug, simeprevir, which was tested in combination with standard hepatitis C drugs, peginterferon-alpha and ribavirin.

The drug is being developed by J&J unit Janssen Research & Development LLC. It is being tested in adults who failed previous interferon-based therapy or had not received medication at all.

The FDA usually follows the recommendation of the advisory panel, although it is not obligated to do so.

Hepatitis C, an infection of the liver transmitted through the blood, kills more than 15,000 Americans each year, mostly from hepatitis C-related illnesses such as cirrhosis and liver cancer.

J&J shares closed at $92.35 on the New York Stock Exchange on Thursday.

(Reporting By Adithya Venkatesan in Bangalore; Editing by Maju Samuel)