PRLog (Press Release) -
Apr 08, 2009 -
Fulford India Limited, Schering- Plough’s majority owned affiliate in India, today announced that it has received approval for its VIRAFERONPEG®*
, the, pegylated interferon therapy in combination with REBETOL® (ribavirin, USP) for retreating adult patients with chronic hepatitis C whose prior treatment with interferon alpha (pegylated or non-pegylated)
and ribavirin combination therapy or interferon alpha monotherapy did not result in a sustained response.
The approval comes close on the heels of the successful EPIC3 clinical study conducted which showed that retreatment with VIRAFERONPEG®*
and REBETOL® combination therapy can result in sustained virologic response (SVR) in certain patients with chronic hepatitis C who failed previous treatment with any alpha interferon-based combination therapy, including peginterferon regimens.
With this local approval in India, VIRAFERONPEG®*
can now be used for re-treatment of a large and growing number of patients who failed previous hepatitis C (HCV) therapy and are in need of viable treatment options. “The VIRAFERONPEG®*
and REBETOL® combination therapy will help address the unmet medical needs of this difficult-to-
treat patient population” said Dr. Nitin Mulgaonkar, Medical Director, Fulford India Limited. VIRAFERONPEG®*
combination therapy is approved for re treatment of HCV patients in Europe and US, and is the first pegylated interferon combination therapy to be approved for the re-treatment of chronic hepatitis C by the European Union and USFDA.
Hepatitis C virus (HCV) infection is a major cause of chronic liver disease and is a significant healthcare problem worldwide. The current standard of care for treating chronic HCV is the combination of VIRAFERONPEG®*
and REBETOL®, which achieves SVR in approximately 50 to 80 percent of patients overall. In India, approximately 12.5 million people are suffering from HCV with the death rate exceeding over a hundred thousand per year.
KG Ananthakrishnan, Managing Director, Fulford India Limited, said, “The approval of VIRAFERONPEG®*
for the re-treatment of chronic Hepatitis offers hope to millions in India and highlights Schering-Plough’
s steadfast commitment to ongoing research in the field of virology, with the aim of improving the health and quality of life for patients”.
The medical community is excited about the possibilities that the approval of the combination therapy offers for re-treatment of non-responders and relapsers. Dr. Deepak Amrapurkar, Consultant Gastroenterologist, Bombay Hospital, said, “This approval represents an option for the large number of hepatitis C patients who failed prior therapy because it gives them a second chance at success. Based on a patient's treatment history, these VIRAFERONPEG®*
data allow physicians to identify which patients in this hard-to-treat population are right for retreatment and are most likely to achieve a sustained response. The predictability of response with VIRAFERONPEG®*
means patients with undetectable virus at week 12 have an even chance of success regardless of whether they failed previous therapy with pegylated or non-pegylated interferon and can be motivated to continue treatment, and those patients who fail to achieve an early response can have their therapy stopped with confidence”.
EPIC3 Clinical Study:
The approval is based on results from the clinical study (EPIC3) in which 1,336 patients with moderate-to-
severe fibrosis or cirrhosis who failed previous treatment with combination alpha interferon/ribavirin therapy were retreated with VIRAFERONPEG®*
combination therapy. In this study, virological response at week 12 of treatment was shown to be an important predictor for achieving a sustained virological response (SVR), with 57 percent of patients who had undetectable virus (HCV- RNA) at week 12 going on to achieve SVR with a 48-week course of therapy. Within this subgroup, the SVR rates were 59 percent and 47 percent for patients who failed prior therapy with non-pegylated or pegylated interferon, respectively. SVR is defined as undetectable HCV-RNA at 24 weeks post-treatment.
About Schering Plough:
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-
development platform to human prescription, animal health and consumer health care products. Schering-
Plough’s vision is to “Earn Trust, Every Day” with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-
plough.com.
It’s local web site is www.fulfordindia.com.
