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Vertex's Hepatitis C Tablet Incivek Gets FDA Approval - Update

Vertex Pharmaceuticals Inc. (VRTX) Monday said that the U.S. Food and Drug Administration or FDA has approved its hepatitis C tablets incivek or telaprevir. The tablets will reach markets this week.

Hepatitis C is a life-threatening liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people. Incivek is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication.

Cambridge, Massachusetts-based Vertex said that incivek is approved for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease including cirrhosis. Compensated liver disease is a condition in which liver has some level of damage but it still functions. Both, people who are new to treatment and people, who did not achieve a viral cure from previous treatment, can use incivek.

The FDA's approval was based on data from three Phase 3 studies. During the treatment, incivek is given for 12 weeks in combination with pegylated-interferon and ribavirin, two other medicines approved for hepatitis C treatment. All patients stop incivek after the first 12 weeks and continue the treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks.

Studies showed that more than 60 percent of the people treated for the first time, as well as those who relapsed after previous therapy achieved significantly higher rates of sustained viral response or SVR with the incivek combination treatment.

In the group of people new to treatment, the SVR for incivek combination was 79 percent, compared with 46 percent for those who received pegylated-interferon and ribavirin alone. Among relapsers, 86 percent achieved higher rates of SVR, versus 22 percent in the pegylated-interferon and ribavirin alone group.

Rash and anemia are the most serious side effects associated with incivek.

Incivek 750 mg is given as two 375-mg tablets three times daily. It is packaged in weekly boxes that include daily blister strips to help patients keep track of their doses.

Vertex developed telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has commercialization rights for telaprevir in North America. It will market telaprevir in the U.S. with the brand name incivek.

Tibotec, through its affiliate Janssen, has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Meanwhile, Mitsubishi Tanabe holds rights to commercialize telaprevir in Japan and certain Far East countries.

The company also stated that it is introducing a comprehensive financial assistance and patient support program to help people get incivek who might not otherwise be able to afford it.

VRTX is trading at $54.79, down $0.21 or 0.37 percent, on a volume of 939,796 shares.

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