FDA Approves Merck Victrelis Oral Hepatitis C Virus Inhibitor–New Class of Medicine
Posted May 14 2011 3:50am
Hepatitis C is getting some good news as last month another drug went into clinical trials. Also Merck will include VICTRELIS in the patient assistance program through which eligible patients may be able to receive product free of charge. This is the first new treatment in 20 years. In the trials more than 65% of the patients were cured, good news there. The dosage is taken 3 times a day, a pill with meals.
Hepatitis C is the primary cause of liver transplants un the US so sales are predicted to be pretty large with over 3 million in the US having the disease. One of the benefits of the drug is that the length of time for a cure is less than current treatments. BD
WHITEHOUSE STATION, N.J., May 13, 2011 – Merck (NYSE:MRK) (known as MSD outside the United States and Canada) announced today that the U.S. Food and Drug Administration (FDA) has approved VICTRELIS™ (boceprevir), the company's innovative new medicine for the treatment of chronic hepatitis C (CHC). VICTRELIS is approved for the treatment of CHC genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
VICTRELIS is the first in a new class of medicines known as hepatitis C virus (HCV) 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.
“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.”
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. Resources include coupons to help eligible patients with their medication cost, reimbursement support to help patients understand their insurance coverage for VICTRELIS, and 24/7 nurse phone support.