Published on 17/12/10 at 10:38am
A new treatment from Janssen which could help cure many more patients with hepatitis C has been submitted in Europe.
Telaprevir is an oral, direct-acting antiviral that treats chronic genotype 1 hepatitis C virus (HCV), the most common form of the virus. Europe's regulator the EMA will fast-track the drug's appraisal, in recognition of its potential to significantly improve treatment of the disease.
Current standard treatment of HCV is pegylated-interferon and ribavirin, but only 40-50% of patients see the virus suppressed to levels where they are considered to be cured.
Clinical trials of telaprevir have shown spectacular results when added to standard therapy, with the drug raising cure rates from 44% to 75 per cent. Moreover the drug achieved these results by 24 weeks, half the time taken by current standard therapy.
The treatment has also shown to help treatment-naïve patients and those who have failed to respond to standard therapy.
The impressive results have led some analysts to predict peak sales of up to $3 billion.
The drug was discovered by Vertex, and is being marketed in Europe by Janssen.
Telaprevir has direct competition in the form of Merck’s boceprevir, which is in the same protease inhibitor class, and is expected to be filed with regulators very shortly.
“Current treatment for hepatitis is lengthy and only effective for approximately half of treatment-naïve patients, and even fewer patients who failed previous treatment,” commented Stefan Zeuzem, Professor of Medicine and chief, department of medicine, J W Goethe University Hospital, Frankfurt.
“If approved, telaprevir would help to significantly improve cure rates and shorten treatment duration for many people living with HCV, compared to current standard treatment.”
Johan Van Hoof, global therapeutic area head infectious diseases and vaccines at Janssen, called the filing a 'landmark' in the HCV treatment and said it demonstrated Janssen's dedication to addressing unmet medical need in infectious diseases.
An estimated 170 million people are living with HCV around the world, including more than five million in Europe.
Chronic HCV can result in serious long-term health problems, and an estimated 30% of patients will develop progressive liver disease, including cirrhosis of the liver, which places them at risk for liver insufficiency and liver cancer. HCV is the most common cause of liver transplant in Europe.