Date: 2011-12-20

Type of information: Granting of a Market Authorisation in the EU

Product name: Incivek®/Incivo®

Compound: telaprevir

Therapeutic area: Infectious diseases

Action mechanism:

Incivek®/Incivo® is a NS3/4A protease inhibitor of the genotype 1 hepatitis C virus. This stops the hepatitis C virus from replicating in the infected host cells of the body. When Incivo is added to  peginterferon alfa and ribavirin (the current standard treatment for hepatitis C) this increases the likelihood of the virus being killed.

Company: Vertex Pharmaceuticals (USA - MA) J&J (USA - NJ)


treatment of patients with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver)

Latest news:

* On September 19, 2011, the European Commission granted a marketing authorisation for Incivo® for the treament of chronic hepatitis C in combination with peginterferon alfa and ribavirin. It is used in adults who have compensated liver disease including cirrhosis (scarring of the liver) either in previously untreated patients or in those who have already been treated with interferon alfa. Incivo® was investigated in three main studies in patients infected with hepatitis C. The first study involved 1,095 previously untreated patients, and the second study involved 663 patients who had already been treated with peginterferon alfa and ribavirin but were still infected. Both studies compared Incivo with placebo (a dummy treatment) added to a course of peginterferon alfa and ribavirin. A third study in previously untreated patients compared the effects of giving peginterferon alfa and ribavirin for different lengths of time (either six months or one year) together with three months of Incivo® treatment. In all three studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus six months after the end of treatment. The European Medicines gency (EMA)' EPAR indicated that in the first study, when Incivo® was given for three months, 75% of patients tested negative for hepatitis C compared with 44% of patients receiving placebo. In the second study, 88% of patients receiving Incivo® for three months tested negative for hepatitis C compared with 24% of patients receiving placebo. The third study showed that in patients treated with Incivo®, giving peginterferon alfa and ribavirin for six months was as effective as giving these medicines for one year, since 92% of patients receiving them for six months tested negative for hepatitis C compared with 88% of patients receiving them for one year. The most common side effects with Incivo® (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), nausea (feeling sick), diarrhoea, vomiting, haemorrhoids (piles), proctalgia (anal pain), pruritus (itching) and rash. 

* On May 23, 2011, FDA has approved Incivek® (telaprevir) for people who are new to treatment, and for people who were treated previously but who did not achieve a viral cure (relapsers, partial responders and null responders).The drug is given for 12 weeks in combination with pegylated-interferon and ribavirin, two other medicines approved to treat hepatitis C. After the first 12 weeks, all patients stop receiving Incivek®and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks of treatment. With Incivek® combination treatment, more than 60 percent of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks — half the time needed if they were to take pegylated-interferon and ribavirin alone. All other patients will receive a total of 48 weeks of treatment. Incivek® (750 mg) is given as two 375-mg tablets three times daily. It is packaged in weekly boxes that include daily blister strips to help patients keep track of their doses. Rash and anemia are the most serious side effects associated with Incivek®. The most common side effects reported with Incivek® combination treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems, and taste changes.


Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2011-05-23

UE authorization: 2011-09-19

Favourable opinion UE: 2011-07-21

Favourable opinion USA: 20114-04-29

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes