FDA Advisory Committee Unanimously Recommends Approval Of Teleprevir For People With Hepatitis C
Monday, May 23, 2011 at 3:29PM Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Antiviral Drugs Advisory Committee to the U.S Food and Drug Administration (FDA) voted unanimously to recommend FDA approval of telaprevir for people with genotype 1 chronic hepatitis C. The Committee recommended by a vote of 18 - 0 the approval of telaprevir for those who were not treated previously and those who were treated previously but not cured with currently available medicines. Telaprevir was studied in all major subgroups of people who were treated previously and not cured: relapsers, partial responders and null responders. The FDA is expected to make a decision on the approval of teleprevir by May 23, 2011 under the Prescription Drug User Fee Act (PDUFA).The FDA is not bound by the Committee's recommendation, but usually follows its advice.
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Approval of INCIVEK (telaprevir), a direct acting antiviral drug (DAA) to treat hepatitis C (HCV)
On May 23, 2011, FDA approved INCIVEK, a hepatitis C virus (HCV) protease inhibitor. INCIVEK is the second direct acting drug against the hepatitis C virus to be approved.
INCIVEK (telaprevir), in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis, who are treatment-naive (patients who have not received interferon-based drug therapy for their infection) or who have previously been treated with interferon-based treatment and not responded adequately, including prior null responders, partial responders, and relapses.
The current standard of care for patients with hepatitis C infection is peginterferon alfa and ribavirin taken for 48 weeks. Less than 50 percent of patients respond to this therapy.
The following points should be considered when initiating treatment with INCIVEK:
- INCIVEK must not be administered as monotherapy and must only be prescribed with both peginterferon alfa and ribavirin.
- A high proportion of previous null responders (particularly those with cirrhosis) did not achieve a Sustained Virologic Response (SVR) and had telaprevir resistance-associated substitutions emerge on treatment with INCIVEK combination treatment.
- INCIVEK efficacy has not been established for patients who have previously failed therapy with a treatment regimen that includes INCIVEK or other HCV NS3/4A protease inhibitors.
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