J&J and Vertex’s hep C drug Incivek approved by FDA
pharmafile | May 24, 2011 | News story | Sales and Marketing | FDA, Incivek, Johnson & Johnson, Vertex, hepatitis C, telaprevir
The FDA has approved Johnson & Johnson/Vertex’s new oral hepatitis C drug Incivek.
Incivek (telaprevir), a protease inhibitor, is now licenced in the US for use in patients with genotype 1 chronic hepatitis C with compensated liver disease, including cirrhosis.
It is approved as a first line treatment, and for previously treated patients who did not achieve a viral cure.
The decision is based on impressive phase III results for the drug that saw 79% of patients using Incivek achieving a viral response – which is tantamount to a cure – compared to just 46% of those on standard treatments.
Vertex said it hoped for a European approval, where its partner Johnson & Johnson holds the marketing rights, by the end of the year.
The drug has been tipped to be a blockbuster as it has shown a higher cure rate than older anti-viral treatments.
Matthew Emmens, chief executive of Vertex, said: “Today marks a turning point in the fight against hepatitis C, particularly for people who have been living with this silent disease for decades, hoping for a better chance of a viral cure.”
Rash and anaemia were the most serious side effects associated with the drug, with the most common side effects including fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems, and taste changes.
The news comes in the same month that its rival Merck received approval for its oral hep C drug Victrelis (boceprevir) for a similar licence, which is also expected to generate blockbuster sales.
Current hepatitis C treatments have seen only limited success and have not proved powerful enough to help a majority of those infected.
The two new and more powerful oral treatments herald the next generation of drugs to fight the disease.
Edward Cox, director of the office of antimicrobial products in FDA’s Center for Drug Evaluation and Research, said: “With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition.”
The decision was widely expected after an FDA advisory panel voted unanimously to recommend the drug last month.
Incivek is given for 12 weeks in combination with current standard treatments pegylated-interferon and ribavirin (Roche’s Pegasys and Copegus), after which patients stop taking the drug and continue treatment with pegylated-interferon and ribavirin alone.
Vertex said Incivek would be launched in the US by the end of the week.
Ben Adams
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