MONDAY, May 23 (HealthDay News) -- The U.S. Food and Drug Administration on Monday approved Incivek (telaprevir), one of a new class of drugs, to fight chronic hepatitis C infection.
The approval comes after the agency gave a thumbs-up on May 13 to another drug in the same class, called Victrelis (boceprevir).
Both pills appear to help more people clear the virus from their system in a shorter time than older drugs for hepatitis C.
In three clinical trials sponsored by the drug's maker, Massachusetts-based Vertex Pharmaceuticals, a much higher percentage of patients responded favorably when Incivek was added to their care vs. the use of older drugs alone. The length of time needed to treat also fell, from 48 weeks to 24 weeks, the FDA said.
"With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition," Dr. Edward Cox, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research, said in a statement. "The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection."
Experts working in the field agreed.
"Both patients and physicians are really excited about the approval of this drug, which represents a huge advance in the treatment of hepatitis C. It is expected to almost double the cure rate of this disease," said Dr. Douglas Dieterich, a professor of medicine in the division of liver diseases, at Mount Sinai School of Medicine in New York City.
"We are all very excited about the approval of a new treatment option for hepatitis C," added Dr. Joseph Rahimian, an infectious disease specialist at NYU Langone Medical Center. "This disease has been very difficult to treat, with limited therapeutic o
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