Merck’s hepatitis drug Victrelis approved by FDA
pharmafile | May 16, 2011 | News story | Sales and Marketing | Merck & Co, Victrelis, boceprevir, hepatitis C
The FDA has approved Merck’s hepatitis C drug Victrelis, the first oral treatment for the disease.
Victrelis (boceprevir) has been licensed to treat hepatitis C genotype 1 infection, in combination with current treatments peginterferon alfa (Roche’s Pegasys) and ribavirin.
Current treatments have seen limited success and have not proved powerful enough to help a majority of those infected.
But Victrelis, a first-in-class hepatitis C virus (HCV) protease inhibitor, heralds a new era of more potent drugs and during recent late stage trials, Merck’s drug clinically cured about two-thirds of patients, compared with less than 40% on current therapies alone.
Because of its impressive trial results and oral formulation, analysts have predicted blockbuster sales of over $1 billion a year at its peak.
Bruce Bacon, a professor of internal medicine and a clinical investigator for the drug, said: “This is an exciting day for physicians and patients because Victrelis is the first major advancement for the treatment of chronic hepatitis C approved in a decade.
“Compared to current standard therapy, Victrelis can significantly increase a patient’s chance of achieving undetectable levels of the virus, thereby obtaining an SVR [sustained virological response].”
Bacon added that Victrelis may also allow for a shorter total duration of treatment because of its effectiveness.
Kenneth Frazier, president and chief executive officer of Merck, said he looked forward to building on his company’s legacy in the fight against infectious diseases, adding he was glad to a part of this ‘exciting new era in the treatment of chronic hepatitis C’.
The approval will be positive news in the US as there are currently over three million Americans with chronic hepatitis C, with around 10,000 deaths a year from the disease.
The FDA has made a speedy decision with Victrelis, fast-tracking the drug for approval in January. It has similar status in Europe, where the EMA is due to rule on the drug within the next month.
Victrelis is now available for use in adult patients with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
Meanwhile, Johnson & Johnson is awaiting an FDA decision on its hep C candidate telaprevir, another protease inhibitor made in conjunction with Vertex Pharmaceuticals.
Ben Adams
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