FDA nod for hepatitis C drug

By Dr. Ananya Mandal, MDMay 17 2011

Merck & Co have finally won the Food and Drugs Administration – FDA’S approval on Friday to sell a new drug considered a major advance against the liver-destroying hepatitis C virus. The drug brand named, Victrelis is expected to help transform treatment of the potentially fatal disease with higher cure rates and shorter courses of therapy for some patients. Merck shares rose 0.6 percent in after-hours trading to $37.33, up from their $37.08 close on the New York Stock Exchange. Approval of Victrelis was widely expected after a FDA advisory panel recommended the drug in an 18-0 vote in April.

The drug has a close competitor from Vertex Pharmaceuticals Inc. that is set to win FDA clearance later this month. Industry analysts predict sales of more than $1 billion annually for each drug with the Vertex product dominating the market.

The new medicines work by blocking a protein called protease that the virus needs to replicate. The generic name for the Merck drug is boceprevir and for the Vertex drug is telaprevir. Boceprevir must be taken three times a day with food.

According to experts tens of thousands of patients have been delaying treatment in anticipation of the new medicines, which still must be taken in combination with older hepatitis drugs. About 170 million people around the world are infected with hepatitis C. In the U.S., 3.2 million people have hepatitis C, a blood-borne disease that can lead to chronic liver problems, liver cancer, cirrhosis and death. The disease is the leading cause of liver transplants in the U.S.

Dr. Eliav Barr, Merck's head of infectious diseases research said, “There are so many patients who are just waiting for a new treatment option. There hasn't been anything new in 10 years… We're just thrilled and can't wait to get the medicine out the door to patients.” He added that Merck was ready to begin shipping the drug within the week.

The cure rate for Victrelis reached 66 percent in Merck's studies, an improvement over the 35 to 40 percent seen with current drugs, but less than the 79 percent reported for newly treated patients given the Vertex drug, telaprevir.

“Victrelis is an important new advance for patients with hepatitis C,” Dr. Edward Cox, head of the FDA office of antimicrobial products, said in a statement. The FDA approved Victrelis for adults with hepatitis C who were never treated or who failed previous treatments.

Both the Merck and Vertex medicines in combination with standard drugs cured some patients in half the time of the current therapy of the injectable drug interferon and a pill called ribavirin. The older drugs require almost a year of treatment and often cause flu-like symptoms that are tough to tolerate.

Prescribing instructions for Victrelis suggest that some patients with early responses to the drug can stop treatment after 28 weeks, while some others can stop at 36 weeks. The most common side effects reported with Victrelis were fatigue, anemia, nausea, headache and taste distortion, the FDA said. The drug label recommends monitoring for anemia.