Merck just received approval this week for boceprevir (Victrelis) from the FDA, and it is expected that telaprevir from Vertex Pharmaceuticals, is next later this month. It is thought by the medical community that this new pair of treatments will set off a new generation of cocktail therapies for millions of patients threatened by hepatitis C. More hepatitis C drugs are in the pipelines of Roche, Pharmasset and Bristol Myers Squibb to further advance the standard of care, promising to wipe out the virus earlier with fewer side effects. The hep C drug market spending may increase from $3 billion to $10 billion as a result.
Bruce Bacon, M.D., professor of internal medicine, Saint Louis University School of Medicine said in a release:
“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. For many patients, Victrelis may allow for a shorter total duration of treatment.”
Victrelis is the first in a new class of medicines known as hepatitis C virus protease inhibitors approved for use in combination with peginterferon alfa and ribavirin, which is the current standard therapy, for the treatment of chronic hepatitis C. Current standard therapy for HCV works to strengthen the body’s natural immune response to the virus, but only about 40% of patients with chronic HCV genotype 1 infection are able to achieve SVR. Victrelis is a Direct Acting Antiviral (DAA) agent that interferes with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme (NS3/4A serine protease).
Kenneth C. Frazier, president and chief executive officer, Merck adds:
“Merck is deeply committed to innovation in bringing forward new medicines that significantly address unmet medical needs, and Victrelis is a shining example of our commitment being realized. We look forward to building on our legacy in the fight against infectious diseases, and to being a part of this exciting new era in the treatment of chronic hepatitis C.”
Aside, Vertex issued the following in an April news release:
“The Antiviral Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) voted unanimously to recommend FDA approval of telaprevir for people with genotype 1 chronic hepatitis C. The Committee recommended by a vote of 18-0 the approval of telaprevir for those who were not treated previously and those who were treated previously but not cured with currently available medicines. Telaprevir was studied in all major subgroups of people who were treated previously and not cured: relapsers, partial responders and null responders. The FDA is expected to make a decision on the approval of telaprevir by May 23, 2011, under the Prescription Drug User Fee Act (PDUFA). The FDA is not bound by the Committee’s recommendation, but usually follows its advice.”
Telaprevir is the first hepatitis C drug currently in development that has demonstrated activity in patients who have failed prior therapy.
Camilla Graham, vice president of global medical affairs at Vertex said:
“I think we’ve set a really high bar. We’re looking for high cure rates for as short a treatment period as possible. To be able to shorten the treatment period to 24 weeks is a big step forward.”
Merck will begin shipping VICTRELIS to pharmacies within a week so that patients will have access to this new medication as soon as possible. In addition, the company is expanding its support of public awareness and education programs for chronic hepatitis C.
Written by Sy Kraft