FDA clears first new hepatitis C drug in 20 years
The U.S. Food and Drug Administration approved on Friday a highly anticipated hepatitis C drug from Merck that is the first new treatment for the virus in 20 years.
The first-of-its-kind pill, Victrelis, has been shown to cure more patients in less time than the older drugs now used.
About 3.2 million people in the United States have Hepatitis C, a blood-borne disease linked to 12,000 deaths a year in the country.
The current two-drug treatment for the virus cures only about 40 percent of people and causes side effects like nausea, fatigue and vomiting.
The FDA said it approved the new drug based on two trials in which more than 65 percent of patients were cured when combining Victrelis with the two older drugs.
Some patients also were able to eliminate the virus in six months on the drug, half the time needed with the current treatments alone.
Boceprevir works by blocking the enzyme protease, a substance that helps hepatitis reproduce. It differs from the older medications, which boost the immune system.
"This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients' hepatitis C infection compared to currently available therapy," said Dr. Edward Cox, director of the FDA's office of antimicrobial products.
The drug is designed to be taken three times a day with meals. Side effects include fatigue, nausea, headache and low blood cell count.
Analysts expect boceprevir to reach annual sales between $800 million and $1 billion. The drug is one of two new hepatitis treatments expected to gain approval this month. Vertex Pharmaceuticals is scheduled to receive a decision on its drug, telaprevir, by May 23. That drug could bring even higher sales of up to $3 billion due to higher efficacy data, according to analyst estimates.
Hepatitis C is the primary cause of liver transplants in the U.S. and is expected to become a much larger public health problem as aging baby boomers succumb to the disease.
People can get the disease by sharing needles or having sex with an infected person. The disease also could be picked up from blood transfusions before 1992, when testing of the blood supply for the virus began.
Most people with hepatitis C do not know they have the virus until after liver damage has occurred, which can cause abdominal pain, fatigue, itching and dark urine.
Current treatment for hepatitis C runs about $30,000. A spokeswoman for Merck, based in New Jersey, could not immediately discuss the drug's price. The company will begin shipping the drug immediately.
"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 hepatitis C," said Merck CEO Kenneth Frazier, in a statement.
Merck & Co. Inc. was the first company to market a drug for hepatitis C in 1991 when it launched interferon-alpha.