US approves breakthrough drug for hepatitis C
Washington: US has approved a breakthrough therapy for treatment of chronic hepatitis C that is expected to offer a more palatable cure to millions of people infected with the liver-destroying viral disease.
Approved by the Food and Drug Administration, the pill, Sovaldi (sofosbuvir) is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon, an official announcement said yesterday.
"Today's (Friday's) approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C," said Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.
Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV (hepatitis C virus) infection.
On November 22, the FDA had approved Olysio (simeprevir).
Sovaldi is marketed by Gilead, based in Foster City, California. Olysio is marketed by Raritan, New Jersey-based Janssen Pharmaceuticals.
FDA said Sovaldi's effectiveness was evaluated in six clinical trials consisting of 1,947 participants who had not previously received treatment for their disease (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants co-infected with HCV and HIV.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.
About 3.2 million Americans are infected with hepatitis C, according to the Centers for Disease Control and Prevention, the CNN said.
Symptoms may include fever, fatigue, loss of appetite, vomiting, nausea, abdominal pain, dark urine, clay-coloured bowel movements, joint pain and jaundice, according to the CDC.