July 18 (Reuters) - Gilead Sciences Inc said on Tuesday that the U.S. Food and Drug Administration approved its hepatitis C drug for patients who had failed to respond to prior treatments.
Vosevi is the first drug to be approved for hepatitis C patients already treated with Sovaldi or other drugs, which inhibit a protein called NS5A, the FDA said in a separate release.
The approval is based on data from two late-stage studies, which evaluated 12 weeks of the drug in previously treated patients, the company said.
However, the approval comes with a boxed warning about the risk of hepatitis B virus being reactivated in patients infected with both hepatitis C and hepatitis B.
Gilead, whose growth has been fueled by its arsenal of hepatitis C drugs, had warned earlier this year that sales of its high-priced drugs were declining due to fewer patients being deemed eligible for treatment and rising competition.
First-quarter sales of the company's hepatitis C drugs, Sovaldi, Harvoni and Epclusa, slumped to $2.6 billion from $4.3 billion a year earlier.
Hepatitis C causes inflammation of the liver that can lead to diminished organ function or its failure. An estimated 2.7 million to 3.9 million people in the United States have chronic hepatitis C infection, according to the Centers for Disease Control and Prevention. (Reporting by Akankshita Mukhopadhyay in Bengaluru; Editing by Anil D'Silva)