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Sr. Executive / Executive, Production; THE IBN SINA PHARMACEUTICAL IND LTD

Approval of Incivek Tablets (telaprevir) by FDA
Brand Name: Incivek Tablets
Generic Name: telaprevir
Company Name: Vertex Pharmaceuticals Incorporated
Date of Approval: May 23, 2011
Treatmant for: Chronic Hepatitis C
Vertex Pharmaceuticals Incorporated today announced that the U.S. Food and Drug Administration (FDA) has approved Incivek (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). Incivek (in-SEE-veck) is approved for people who are new to treatment, and for people who were treated previously but who did not achieve a viral cure (relapsers, partial responders and null responders). Incivek is given for 12 weeks in combination with pegylated-interferon and ribavirin, two other medicines approved to treat hepatitis C. After the first 12 weeks, all patients stop receiving Incivek and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks of treatment. With Incivek combination treatment, more than 60 percent of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks ó half the time needed if they were to take pegylated-interferon and ribavirin alone. All other patients will receive a total of 48 weeks of treatment. Incivek will arrive in pharmacies this week.

The approval of Incivek was based on data from three Phase 3 studies, which showed that people who received Incivek combination treatment achieved significantly higher rates of sustained viral response (SVR, or viral cure) compared to those who received pegylated-interferon and ribavirin alone, regardless of their prior treatment experience:
  • People new to treatment: 79 percent vs. 46 percent

  • People who were treated previously but did not achieve a viral cure:

    1. Relapsers: 86 percent vs. 22 percent

    2. Partial responders: 59 percent vs. 15 percent Null responders: 32 percent vs. 5 percent

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.

Rash and anemia are the most serious side effects associated with Incivek. The most common side effects reported with Incivek combination treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems, and taste changes.

"Hepatitis C can lead to liver failure, cancer and the need for a transplant, and for the past decade, the best we could offer patients was a year of difficult treatment that resulted in a viral cure for fewer than half of them," said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College and principal investigator for a Phase 3 study of Incivek. "With Incivek, 79 percent of people new to treatment achieved a viral cure."

"Today marks a turning point in the fight against hepatitis C, particularly for people who have been living with this silent disease for decades, hoping for a better chance of a viral cure," said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex. "The approval of Incivek was only possible thanks to more than 4,000 people who volunteered for our clinical studies, the doctors, nurses and coordinators who managed the studies, and our own pioneering scientists who have worked for more than 15 years to bring this new medicine to people with hepatitis C."

Vertex has 200 field-based employees across the United States, including a 115-person sales team, who are ready to support the introduction of Incivek. The sales team has an average of more than 14 years of experience bringing medicines to people who need them, including eight years of direct experience with antiviral medicines for diseases such as hepatitis C.
Note: To know more please go to the following sources.
Update: 2011-05-23
Source: & FDA
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