Magazin
2008-12-04
Basel (ots/PRNewswire) -
- Pegasys is the First and Only Pegylated Interferon to beApproved for Treatment of up to 72 Weeks in Treatment-ExperiencedPatients
Roche announced today that the European Commission has approvedPegasys(R) (peginterferon alfa-2a (0 KD)) plus Copegus(R) (ribavirin)for the retreatment of hepatitis C patients who were not successfullytreated with an initial course of interferon alpha (pegylated ornon-pegylated), either alone or in combination with ribavirin.
Although exciting advances in the treatment of hepatitis C havebeen made in recent years, a significant number of patients do notachieve treatment success (sustained virological response (SVR)widely equated to cure(1)) with their first treatment. This resultsin a large and growing population of patients who urgently needalternative treatment solutions. Today's approval provides asignificantly broader indication for peginterferon alfa-2a andestablishes a new standard of care for treatment-experienced patientswith the most difficult-to-treat virus.
"This new indication for Pegasys plus Copegus is anotherdemonstration of Roche's commitment to extend the promise of a cureto as many chronic hepatitis C patients as possible," said William M.Burns, CEO, Roche Pharmaceuticals Division. "Our approach is tooptimise and individualise treatment to increase patients' chance ofsuccess with Pegasys and Copegus, while establishing them as thebackbone for combination with novel agents in development, both byRoche and through external partnerships and collaborations".
The new label for treatment-experienced patients contains severalaspects of Personalised Healthcare, a major focus for Roche whichseeks to tailor medicines for better disease management:
- The recommended length of peginterferon alfa-2a treatment forpatients is based on their virus genotype and type of priortreatment. For patients with genotype 1 virus who did not respond toinitial treatment with pegylated interferon and ribavirin, it isrecommended that they be retreated with peginterferon alfa-2a for anextended period of 72 weeks. Peginterferon alfa-2a is now the firstand only pegylated interferon to be approved for a 72-week treatmentduration in this patient population. For all othertreatment-experienced patients, the recommended treatment period is48 weeks.
- The label recommends that after 12 weeks of treatment, apatient's virus levels be measured to determine whether a full courseof treatment is likely to result in a cure.
A large, Roche-sponsored study called REPEAT demonstrated that 72weeks of retreatment with peginterferon alfa-2a plus ribavirindoubled the chance of a achieving a cure, compared to 48 weeks, inpatients who were prior non-responders to PegIntron(TM)(peginterferon alfa-2b) and ribavirin. Furthermore, the study showedthat 57% of patients who responded by week 12 (defined as HCV RNAlevels of less than 50 IU/mL) went on to achieve a cure with 72 totalweeks of retreatment.
"The high predictability of response at week 12 with Pegasys plusCopegus should be an important factor when considering whether toretreat hepatitis C," said Prof Patrick Marcellin, Professor ofHepatology at the University of Paris and Head of the Viral HepatitisResearch Unit in Hôpital Beaujon, Clichy, France. "It means thatphysicians and patients will be able to determine -- after only threemonths -- whether treatment is likely to result in a cure".
The safety profile for peginterferon alfa-2a plus ribavirin inprior non-responders was similar to that seen in patients beingtreated for the first time. Further analyses of the 72-week treatmentin REPEAT showed a favourable benefit/risk ratio for the longerduration, because more patients were able to achieve a cure than with48 weeks of therapy.(2) The most common side effects of treatment areflu-like symptoms, fatigue, depression and haematologicalabnormalities.
About Hepatitis C
The hepatitis C virus (HCV) is transmitted primarily throughblood or blood products. HCV chronically affects 180 million peopleworldwide, which makes it over four times more prevalent thanHIV.(3-4) It is a leading cause of cirrhosis, liver cancer and liverfailure, despite the fact that many patients can be cured. In Europealone, HCV is estimated to cause more than 86,000 deaths everyyear.(5)
A recent study examining the HCV-related burden of disease in 22European countries estimated that 7.3-8.8 million people are infectedwith HCV, representing 1.1-1.3% of the population. The report alsofound that no uniform HCV surveillance exists at the European level,and that authorities need to work on an EU-wide, consistentsurveillance system for HCV.6
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-focused healthcare groups in the fields ofpharmaceuticals and diagnostics. As the world's biggest biotechcompany and an innovator of products and services for the earlydetection, prevention, diagnosis and treatment of diseases, the Groupcontributes on a broad range of fronts to improving people's healthand quality of life. Roche is the world leader in in-vitrodiagnostics and drugs for cancer and transplantation, a market leaderin virology and active in other major therapeutic areas such asautoimmune diseases, inflammation, metabolic disorders and diseasesof the central nervous system. In 2007 sales by the PharmaceuticalsDivision totalled 36.8 billion Swiss francs, and the DiagnosticsDivision posted sales of 9.3 billion Swiss francs. Roche has R&Dagreements and strategic alliances with numerous partners, includingmajority ownership interests in Genentech and Chugai, and investedover 8 billion Swiss francs in R&D in 2007. Worldwide, the Groupemploys about 80,000 people. Additional information is available onthe Internet at http://www.roche.com/ http://www.roche.com .
All trademarks used or mentioned are protected by law.
References 1. Swain M, Lai M, Shiffman M, Cooksley W et al. Sustained virologic response (SVR) resulting from treatment with peginterferon alfa-2a (40KD) (PEGASYS(R)) alone or in combination with ribavirin (COPEGUS(R)) is durable and constitutes a cure: an ongoing 5-year follow-up. Abstract presented at Digestive Disease Week; 21 May 2007; Los Angeles, California, USA. 2. Marcellin P, Craxi A, Brandão-Mello C, Di Bisceglie A. A 72-week treatment duration with peginterferon alfa-2a (40KD) (PEGASYS) plus ribavirin (COPEGUS) has a favorable risk:benefit ratio in non- responders to pegylated interferon alfa-2b (12KD) plus ribavirin: findings of the multinational REPEAT study. Abstract presented at the American Association for the Study of Liver Disease; 31 October 2008; San Francisco, California, USA. 3. AIDS Epidemic Update. 2006. (Accessed October 26, 2007, at http://www.who.int/hiv/mediacentre/2006_EpiUpdate_en.pdf.) 4. World Health Organization. Initiative for Vaccine Research, Viral Cancers, Hepatitis C. 2006. (Accessed July 24, 2006, at http://www.who.int/vaccine_research/diseases/viral_cancers/en/index2.html.) 5. Siebert U, Muhlberger N and Zeuzem S. Pan European Perspectives on Hepatitis C. Volume 1: Burden of Disease. Pg. 10. 6. Siebert U, Muhlberger N and Zeuzem S. Pan European Perspectives on Hepatitis C. Volume 1: Burden of Disease. Pgs. 6 and 8.
Roche Group Media Office: Phone: +41-61-688-8888 / Email: basel.mediaoffice@roche.com - Elina Ämmälä - Daniel Piller (Head) - Alexander Klauser - Martina Rupp - Claudia Schmitt
ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de
Contact:Roche Group Media Office: Phone: +41-61-688-8888 / Email: basel.mediaoffice@roche.com
European Commission Approval of New Indication for Roche's Pegasys(R) (peginterferon alfa-2a) Offers Hepatitis C Patients a Second Chance for a Cure
- Pegasys is the First and Only Pegylated Interferon to beApproved for Treatment of up to 72 Weeks in Treatment-ExperiencedPatients
Roche announced today that the European Commission has approvedPegasys(R) (peginterferon alfa-2a (0 KD)) plus Copegus(R) (ribavirin)for the retreatment of hepatitis C patients who were not successfullytreated with an initial course of interferon alpha (pegylated ornon-pegylated), either alone or in combination with ribavirin.
Although exciting advances in the treatment of hepatitis C havebeen made in recent years, a significant number of patients do notachieve treatment success (sustained virological response (SVR)widely equated to cure(1)) with their first treatment. This resultsin a large and growing population of patients who urgently needalternative treatment solutions. Today's approval provides asignificantly broader indication for peginterferon alfa-2a andestablishes a new standard of care for treatment-experienced patientswith the most difficult-to-treat virus.
"This new indication for Pegasys plus Copegus is anotherdemonstration of Roche's commitment to extend the promise of a cureto as many chronic hepatitis C patients as possible," said William M.Burns, CEO, Roche Pharmaceuticals Division. "Our approach is tooptimise and individualise treatment to increase patients' chance ofsuccess with Pegasys and Copegus, while establishing them as thebackbone for combination with novel agents in development, both byRoche and through external partnerships and collaborations".
The new label for treatment-experienced patients contains severalaspects of Personalised Healthcare, a major focus for Roche whichseeks to tailor medicines for better disease management:
- The recommended length of peginterferon alfa-2a treatment forpatients is based on their virus genotype and type of priortreatment. For patients with genotype 1 virus who did not respond toinitial treatment with pegylated interferon and ribavirin, it isrecommended that they be retreated with peginterferon alfa-2a for anextended period of 72 weeks. Peginterferon alfa-2a is now the firstand only pegylated interferon to be approved for a 72-week treatmentduration in this patient population. For all othertreatment-experienced patients, the recommended treatment period is48 weeks.
- The label recommends that after 12 weeks of treatment, apatient's virus levels be measured to determine whether a full courseof treatment is likely to result in a cure.
A large, Roche-sponsored study called REPEAT demonstrated that 72weeks of retreatment with peginterferon alfa-2a plus ribavirindoubled the chance of a achieving a cure, compared to 48 weeks, inpatients who were prior non-responders to PegIntron(TM)(peginterferon alfa-2b) and ribavirin. Furthermore, the study showedthat 57% of patients who responded by week 12 (defined as HCV RNAlevels of less than 50 IU/mL) went on to achieve a cure with 72 totalweeks of retreatment.
"The high predictability of response at week 12 with Pegasys plusCopegus should be an important factor when considering whether toretreat hepatitis C," said Prof Patrick Marcellin, Professor ofHepatology at the University of Paris and Head of the Viral HepatitisResearch Unit in Hôpital Beaujon, Clichy, France. "It means thatphysicians and patients will be able to determine -- after only threemonths -- whether treatment is likely to result in a cure".
The safety profile for peginterferon alfa-2a plus ribavirin inprior non-responders was similar to that seen in patients beingtreated for the first time. Further analyses of the 72-week treatmentin REPEAT showed a favourable benefit/risk ratio for the longerduration, because more patients were able to achieve a cure than with48 weeks of therapy.(2) The most common side effects of treatment areflu-like symptoms, fatigue, depression and haematologicalabnormalities.
About Hepatitis C
The hepatitis C virus (HCV) is transmitted primarily throughblood or blood products. HCV chronically affects 180 million peopleworldwide, which makes it over four times more prevalent thanHIV.(3-4) It is a leading cause of cirrhosis, liver cancer and liverfailure, despite the fact that many patients can be cured. In Europealone, HCV is estimated to cause more than 86,000 deaths everyyear.(5)
A recent study examining the HCV-related burden of disease in 22European countries estimated that 7.3-8.8 million people are infectedwith HCV, representing 1.1-1.3% of the population. The report alsofound that no uniform HCV surveillance exists at the European level,and that authorities need to work on an EU-wide, consistentsurveillance system for HCV.6
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-focused healthcare groups in the fields ofpharmaceuticals and diagnostics. As the world's biggest biotechcompany and an innovator of products and services for the earlydetection, prevention, diagnosis and treatment of diseases, the Groupcontributes on a broad range of fronts to improving people's healthand quality of life. Roche is the world leader in in-vitrodiagnostics and drugs for cancer and transplantation, a market leaderin virology and active in other major therapeutic areas such asautoimmune diseases, inflammation, metabolic disorders and diseasesof the central nervous system. In 2007 sales by the PharmaceuticalsDivision totalled 36.8 billion Swiss francs, and the DiagnosticsDivision posted sales of 9.3 billion Swiss francs. Roche has R&Dagreements and strategic alliances with numerous partners, includingmajority ownership interests in Genentech and Chugai, and investedover 8 billion Swiss francs in R&D in 2007. Worldwide, the Groupemploys about 80,000 people. Additional information is available onthe Internet at http://www.roche.com/ http://www.roche.com .
All trademarks used or mentioned are protected by law.
References 1. Swain M, Lai M, Shiffman M, Cooksley W et al. Sustained virologic response (SVR) resulting from treatment with peginterferon alfa-2a (40KD) (PEGASYS(R)) alone or in combination with ribavirin (COPEGUS(R)) is durable and constitutes a cure: an ongoing 5-year follow-up. Abstract presented at Digestive Disease Week; 21 May 2007; Los Angeles, California, USA. 2. Marcellin P, Craxi A, Brandão-Mello C, Di Bisceglie A. A 72-week treatment duration with peginterferon alfa-2a (40KD) (PEGASYS) plus ribavirin (COPEGUS) has a favorable risk:benefit ratio in non- responders to pegylated interferon alfa-2b (12KD) plus ribavirin: findings of the multinational REPEAT study. Abstract presented at the American Association for the Study of Liver Disease; 31 October 2008; San Francisco, California, USA. 3. AIDS Epidemic Update. 2006. (Accessed October 26, 2007, at http://www.who.int/hiv/mediacentre/2006_EpiUpdate_en.pdf.) 4. World Health Organization. Initiative for Vaccine Research, Viral Cancers, Hepatitis C. 2006. (Accessed July 24, 2006, at http://www.who.int/vaccine_research/diseases/viral_cancers/en/index2.html.) 5. Siebert U, Muhlberger N and Zeuzem S. Pan European Perspectives on Hepatitis C. Volume 1: Burden of Disease. Pg. 10. 6. Siebert U, Muhlberger N and Zeuzem S. Pan European Perspectives on Hepatitis C. Volume 1: Burden of Disease. Pgs. 6 and 8.
Roche Group Media Office: Phone: +41-61-688-8888 / Email: basel.mediaoffice@roche.com - Elina Ämmälä - Daniel Piller (Head) - Alexander Klauser - Martina Rupp - Claudia Schmitt
ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de
Contact:Roche Group Media Office: Phone: +41-61-688-8888 / Email: basel.mediaoffice@roche.com
Roche Pharmaceuticals
