J&J’s hep C drug Incivo approved in Europe
pharmafile | September 22, 2011 | News story | Sales and Marketing | Incivek, Incivo, Victrelis
J&J’s potential blockbuster hepatitis C treatment Incivo has been approved in Europe.
Incivo (telaprevir) was approved in combination with peginterferon alfa and ribavirin, having demonstrated significant improvements in cure rates during three phase III studies.
“We are delighted by the European Commission approval of telaprevir and that we can now offer patients a significantly improved treatment option for hepatitis C virus (HCV) compared to the previous standard treatment,” said Ramon Polo, Telaprevir Compound Development team leader.
Incivo, known as Incivek in the US where it was approved in May, will now go head-to-head with another groundbreaking hep C medicine, Merck’s Victrelis.
Victrelis (boceprevir) was given the green light in Europe in July and is also expected to reach blockbuster status.
Both treatments are direct-acting antivirals, but Incivo may have an edge over its rival, having previously demonstrated a higher cure rate, and a simpler and faster simpler dosing regimen.
The UK’s watchdog NICE has already announced its intention to appraise both drugs on their cost and clinical effectiveness.
Charles Gore of the World Hepatitis Alliance said: “Hepatitis C can be a devastating disease; however, if treated successfully, patients can avoid life-threatening liver problems such as further liver damage, cirrhosis, liver failure and liver cancer.
“The arrival of Direct Acting Antivirals is the first treatment breakthrough in more than 10 years and a significant step forward for the hepatitis C community. It will offer more patients hope for a cure.”
HCV is a blood-borne infectious disease that affects the liver. J&J estimates that 170 million people are infected worldwide with three to four million people newly infected each year. Chronic infection with HCV can lead to liver cancer and other serious and fatal liver diseases.
Brett Wells
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