Regulators fast-track Merck’s hepatitis C drug boceprevir
pharmafile | January 7, 2011 | News story | Sales and Marketing | Merck & Co, boceprevir, hepatitis C, telaprevir
Merck’s new oral hepatitis C drug boceprevir will receive fast track reviews from both the FDA and the EMA after the regulators decided it marked a major advance in treatment.
The FDA has granted Merck’s investigational protease inhibitor priority review status, a move that could see the drug on the market within six months.
The US regulator’s European counterpart the EMA has also accepted the marketing Merck’s boceprevir application for accelerated assessment.
Dr Peter Kim, president of Merck research laboratories, said: “We are pleased that the FDA and EMA have accepted boceprevir for expedited review.
“Our goal is to be able to bring forward a new treatment option for patients living with chronic hepatitis C, and we are now closer to that goal.”
Current standard treatment of HCV is pegylated-interferon and ribavirin, but only 40-50% of patients see the virus suppressed to levels where they are considered to be cured.
Merck’s submission is based on two recent late stage trials that saw 66% of patients on boceprevir plus standard drugs for a full 48 weeks cured of the serious liver disease, a significantly higher cure rate than for standard treatment alone.
Boceprevir will be in direct competition with Janssen’s its oral hep C drug telaprevir, which was submitted to the EU last month after late stage trials demonstrated strong results when added to standard therapy, with the drug raising cure rates from 44% to 75 per cent.
According to analysts at EvaluatePharma, telaprevir is expected to make over $800 million a year by 2016.
Ben Adams
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