Hep C drug Victrelis gains EU approval
pharmafile | July 20, 2011 | News story | Sales and Marketing | Incivek, Victrelis, hepatitis C
Merck Sharp & Dohme’s Victrelis, one of two major new hepatitis C drugs, has gained final approval in Europe.
Victrelis (boceprevir) is the first licensed product in a new class of medicines to treat hepatitis C, but will soon face stiff competition from Incivek (telaprevir), which will be marketed by Johnson & Johnson in Europe.
Victrelis is indicated to treat chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
The drug is the first direct acting antiviral agent targeting the hepatitis C virus, to be licensed by the EMA. It works by interfering with viral replication by inhibiting a key viral enzyme (NS3 serine protease).
Victrelis was approved through the accelerated assessment due to its major public health interest, and is now cleared for launch across the EU’s 27 member states, as well as Iceland, Liechtenstein and Norway.
MSD’s UK medical director Paul Robinson said: “We are delighted the EMA has granted marketing authorisation to boceprevir in combination with current standard therapy.
“Boceprevir represents the first licensed drug in a new class of medicines and the first drug to be granted marketing authorisation for HCV treatment in 10 years. MSD is proud to deliver innovative health solutions and provide a new treatment option for patients with chronic hepatitis C genotype 1.”
The EMA decision is based on results from two large phase III clinical studies conducted at EU and US sites that evaluated around 1,500 adult patients with chronic HCV genotype 1 infection.
The HCV SPRINT-2 study involved 1,097 patients who were new to treatment (‘treatment-naïve’) and the HCV RESPOND-2 study involved 403 patients who had failed previous therapy. Final results of the studies were published in the New England Journal of Medicine in March this year.
Victrelis in combination with standard of care, showed encouraging statistically significant improvements in sustained virological responses or cure rates compared to standard of care alone, with a manageable toxicity and side effect profile.
Challenge from Incivek
Victrelis is expected to reach blockbuster status, but will face stiff competition from J&J and Vertex’s Incivek.
Victrelis had a 66% sustained viralogic response (SVR) – as close to a cure as possible – in late-stage studies, but Incivek produced a significantly higher rate of 79 per cent.
Incivek has a further advantage – patients who respond well to the drug can stop treatment at just 24 weeks rather than the much longer 48 weeks of the current drug regimen. Safety data suggests Incivek is generally well-tolerated, but about half of patients developed a skin rash or itching, while a small number developed the severe Stevens-Johnson Syndrome.
Merck’s Victrelis has a few factors in its favour – it is likely to cost less (depending on the duration of treatment) and has had no cases of the Stevens-Johnson Syndrome. However Merck’s drug has a more complicated dosing regimen, which is expected to count against it.
Merck is not yet disclosing which countries in Europe it is hoping to launch the product in first, and will have to finalise pricing and reimbursement agreements.
In terms of price, MSD says it will work with local authorities to ensure its price would reflect “the innovation and value that this new therapeutic advancement represents”, and said it would also take local market prices of other HCV medicines into account.
The UK’s NICE has already confirmed Victrelis and Incivek for forthcoming appraisals of their cost and clinical effectiveness.
Andrew McConaghie
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