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FDA committee recommends approval of Pegasys with Copegus.
2002 DEC 27 - (NewsRx.com & NewsRx.net) -- Roche announced that the U.S. Food and Drug Administration (FDA) Anti-Viral Drugs Advisory Committee (AVDAC) unanimously voted to recommend marketing approval of Pegasys (peginterferon alfa-2a) in combination with Copegus (ribavirin) for the treatment of chronic hepatitis C.
AVDAC's vote to recommend approval was made after Roche presented results of two pivotal phase III clinical trials that demonstrate combination therapy with Pegasys and Copegus is a more effective treatment for patients with chronic hepatitis C than treatment with interferon alfa-2b and ribavirin or Pegasys monotherapy.
Pegasys, in combination with Copegus, was granted 6-month priority review status in July of this year and Roche anticipates action on the file by the end of the year. This designation is granted to biologics and drugs that if approved, address unmet medical needs, offering a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease, according ...
- Pegasys in combination with Copegus approved in the US for the treatment of...
- Press release article from: PR Newswire December 4, 2002 700+ words
...the treatment of hepatitis C. Pegasys and Copegus combination therapy was granted...Copegus. About Pegasys and Copegus Pegasys is available as a ready-to...of Copegus and duration for Pegasys/Copegus therapy is based on viral genotype...
- PEGASYS and COPEGUS Achieve Highest Sustained Virological Response Ever...
- Press release article from: PR Newswire February 12, 2004 700+ words
...found that the combination of PEGASYS and COPEGUS achieved a 40% sustained virological...Based on an SVR of 40%, PEGASYS + COPEGUS is the preferred treatment...relevant trial establishes PEGASYS and COPEGUS as the new standard of care...
- FDA Approves Pegasys(R) (peginterferon alfa-2a) in Combination with Copegus(TM)...
- Press release article from: PR Newswire December 4, 2002 700+ words
...Child-Pugh class A). Pegasys and Copegus combination therapy was granted...duration of treatment with Pegasys and Copegus and the dose of Copegus therapy...C a new treatment choice-Pegasys and Copegus combination therapy." "Different...
- Results of Multinational Trial Investigating Pegasys(R) and Copegus(R) in...
- Press release article from: PR Newswire February 7, 2004 700+ words
...showed that a combination of Pegasys and Copegus produced significantly higher...different dosing regimens of Pegasys and Copegus. The treatment regimens and...for these groups treated with Pegasys and Copegus therapy were: -- Genotype...
- PEGASYS And COPEGUS Now Offers Benefits In A Wider Range Of Hepatitis C...
- Press release article from: PR Newswire April 15, 2004 700+ words
...ALT)-demonstrate that PEGASYS plus COPEGUS is an effective, safe and...found that the combination of PEGASYS and COPEGUS achieved a 40% sustained...doubt that the combination of PEGASYS and COPEGUS represents the best we can...
- New Data On Efficacy and Safety of Pegasys and Copegus In Special Populations...
- Press release article from: PR Newswire October 23, 2003 700+ words
...of ribavirin. The following Pegasys and Copegus data will be presented and...the efficacy and safety of Pegasys and Copegus in African American versus...of the multicenter study of Pegasys and Copegus in African American and Caucasian...
- Roche Dramatically Reduces Cost of Combination Therapy for Millions of...
- Press release article from: PR Newswire January 13, 2003 700+ words
...5.06 per 200mg tablet. Pegasys and Copegus combination therapy was approved...Executive Officer. "With Pegasys and Copegus, physicians and patients can...indication and two for the Pegasys and Copegus combination therapy indication...
- Roche's Investigational Polymerase Inhibitor, Combined with PEGASYS(R) and...
- Press release article from: PR Newswire November 2, 2007 700+ words
...plus COPEGUS in comparison to PEGASYS/COPEGUS, the standard of care. The...1500 mg (twice- daily) + PEGASYS + COPEGUS had an undetectable HCV viral...patients receiving R1626 1500 mg + PEGASYS + COPEGUS), and was the main reason...