US approves second new hepatitis C drug

May 23, 2011

The US Food and Drug Administration on Monday approved Incivek to treat hepatitis C when taken along with the current two-drug regimen, marking the second such drug approval this month.

"The sustained virologic response for patients treated with Incivek across all studies, and across all patient groups, was between 20 and 45 percent higher than current standard of care," the FDA said.

Incivek is a pill that should be taken three times a day with food, and is added to therapy made up of peginterferon alfa and ribavirin.

In mid-May, the US regulatory agency approved a Merck-made pharmaceutical known as Victrelis. Both have been shown to boost cure rates when added to the present regimen, which helps fewer than 50 percent of people with the liver disease.

The existing two-drug treatment of pegylated interferon and ribavirin for genotype 1 chronic was approved by US regulators in 1998.

"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," said Edward Cox, director of the office of antimicrobial products in FDA's Center for Drug Evaluation and Research.

"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 infection."

Incivek, or telaprevir, is marketed by the Massachusetts-based .

Explore further: FDA warns doctors to beware fake drug distributors

add to favorites email to friend print save as pdf

Related Stories

US regulators approve new hepatitis C drug

May 14, 2011

US regulators on Friday approved the first new treatment for hepatitis C in more than a decade, a Merck pharmaceutical known as Victrelis, to be taken with the current two-drug regimen.

US panel gives nod to Merck hepatitis C drug

Apr 27, 2011

A US government advisory committee on Wednesday unanimously voted to urge the Food and Drug Administration to approve a new drug made by Merck to fight hepatitis C, a disease which attacks the liver.

Hepatitis C study shows superior viral cure rate

Nov 02, 2010

For patients with the most common form of hepatitis C being treated for the first time, the addition of an investigational hepatitis C–specific protease inhibitor called telaprevir to the current standard therapy markedly ...

Recommended for you

Discount generic drug programs grow over time

18 hours ago

Generic discount drug programs (GDDPs, which charge nominal fees to fill prescriptions) have grown over time and their initial lower use by racial/ethnic minorities has evaporated, writes author Song Hee Hong, Ph.D., of the ...

Seniors successfully withdraw from meds

Sep 19, 2014

Elderly people have proved receptive to being de-prescribed medications, as part of a trial aimed at assessing the feasibility of withdrawal of medications among older people.

User comments : 0