Europe approves Janssen’s hep C drug Olysio
pharmafile | May 20, 2014 | News story | Research and Development, Sales and Marketing | Janssen, hepatitis C, sovaldi
Janssen-Cilag International’s Olysio has been given marketing authorisation in the European Union for the treatment of adults with hepatitis C (HCV) genotype 1 and 4 infection.
The European Commission authorisation includes the drug as part of an all-oral 12-week interferon-free regimen with or without ribavirin, in patients who cannot have interferon. It can also be used in combination with Gilead Sciences’ Sovaldi (sofosbuvir) in some patients.
An estimated nine million people in Europe live with the viral disease, leading to 86,000 deaths in the region each year.
It causes inflammation of the liver and can lead to that organ’s failure: HCV can go on to cause bleeding, jaundice, fluid accumulation in the abdomen, infections or even liver cancer.
Protease inhibitor Olysio (simeprevir) blocks a specific protein needed by the virus to replicate: the drug was approved in the US last year following a priority review.
“The EC marketing authorisation for simeprevir is a great milestone as it adds an important new treatment option for patients, demonstrating the continued role of triple therapy in the treatment of HCV,” says Thomas Stark, Janssen’s EMEA medical director.
“In addition, the introduction of an all oral, 12-week interferon-free treatment regimen provides a new option for sustained virologic response in HCV patients with genotypes 1 or 4 intolerant to or ineligible for interferon-based treatment,” he adds.
Five clinical studies of Olysio showed that in 80% of treatment-naïve patients receiving Olysio, plus peginterferon-alfa and ribavirin, the virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response), suggesting the infection had been cured.
Of those patients receiving placebo plus peginterferon-alfa and ribavirin, only 50% achieved sustained virologic response.
In one study, 79% of patients in the Olysio arm whose infection returned achieved sustained virologic response, compared to 37% in the placebo arm.
This is a potentially lucrative area for manufacturers: the market for hepatitis C drugs could rise to being worth more than $100 billion over the next decade, according to Bloomberg Industries.
The World Health Organization and the European Association for the Study of the Liver estimate that 150 million people worldwide were chronically infected with HCV in 2011, with the virus responsible for 350,000 deaths globally.
Other protease inhibitors – such as Merck’s Victrelis (boceprevir) and Vertex Pharmaceuticals’ Incivek (telaprevir) – are already on the market.
But Sovaldi is the stand-out leader, bringing in eye-watering sales of $2.27 billion in the first three months of 2014 alone, beating an average of analyst estimates by more than $1 billion, and is set to reach $10 billion a year in peak sales.
Adam Hill
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