Merck’s hepatitis drug gets final FDA approval

May 14, 2011|By Matthew Perrone, Associated Press

Mercks drug is expected to reach annual sales up to $1 billion. (Mel Evens/Associated Press/file…)

WASHINGTON — The Food and Drug Administration approved a highly anticipated hepatitis C drug from Merck & Co. yesterday 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 drugs now used.

Vertex Pharmaceuticals Inc., based in Cambridge, has a similar drug awaiting FDA approval. The Vertex drug, which will be called Incivek, got a unanimous recommendation from an FDA advisory committee in late April. Full FDA approval of the drug is expected by May 23.

About 3.2 million people in the United States have hepatitis C, a blood-borne disease linked to 12,000 deaths a year.

The current two-drug treatment for the virus cures only about 40 percent of people and causes side effects such as 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 were also able to eliminate the virus in seven months on the drug, half the time needed with the current treatments alone.

The drug works by blocking the enzyme protease that helps hepatitis reproduce. It differs from the older medications that 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, known generically as boceprevir, 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. Vertex’s drug could garner sales of up to $3 billion due to higher efficacy data, according to analysts.

Hepatitis C is the primary cause of liver transplants in the United States and is expected to become a much larger public health problem as aging baby boomers succumb to the disease.