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Merck & Co. won U.S. approval for the first hepatitis C drug in almost a decade after studies showed it cured more patients than existing treatments.

The Food and Drug Administration cleared boceprevir to treat people with chronic hepatitis C in combination with interferon-based therapy, the agency said today in a statement. The drug will be sold under the name Victrelis.

Merck is competing with Vertex Pharmaceuticals Inc. (VRTX) to become the first company since 2002 to market a new medicine for the liver disease. The drugmakers are among about a dozen companies seeking to offer hepatitis C treatments that cure more patients than standard therapy with fewer side effects. Vertex, based in Cambridge, Massachusetts, expects an FDA decision on its drug by May 23.

“Victrelis is an important new advance for patients with hepatitis C,” Edward Cox, director of the FDA’s Office of Antimicrobial Products, said in the statement. “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.”

Merck plans to start shipping the drug to pharmacies within a week, Pamela Eisele, a company spokeswoman, said in an e-mail. The agency cleared the medicine for use in patients who still have some liver function and failed previous drug therapies or are new to treatment.

Sales Estimates

Sales of Victrelis may surpass $727 million in 2014, according to the average estimate of five analysts surveyed by Bloomberg.

Merck, the second-biggest U.S. drugmaker, rose 17 cents to $37.25 at 5:26 p.m. in extended trading after declining 12 cents to $37.08 at the close of New York Stock Exchange composite trading. Vertex lost 95 cents, or 1.7 percent, to $56.53 in extended trading after falling 53 cents to $57.48 at the close of Nasdaq Stock Market trading.

About 170 million people worldwide, and 3.2 million in the U.S., have chronic hepatitis C, a bloodborne disease that can lead to liver cirrhosis and cancer, according to the Centers for Disease Control and Prevention in Atlanta. No vaccine exists for the virus, which is commonly spread through needle-sharing and can be transmitted sexually in rare cases.

“Merck is deeply committed to innovation in bringing forward new medicines that significantly address unmet medical needs, and Victrelis is a shining example of our commitment being realized,” Kenneth Frazier, Merck’s chief executive officer, said in a statement.

Panel Recommendations

The current standard therapy for the most common strain of hepatitis C requires 48 weeks of treatment and fails in about half of patients, Debra Birnkrant, director of the FDA’s Division of Antiviral Products, told outside advisers to the agency who met last month to evaluate Merck’s boceprevir and Vertex’s telaprevir. The 18-member panel recommended approval of both drugs in unanimous votes.

Standard treatments combine the antiviral drug ribavirin with peginterferon, an immune-boosting protein sold by Merck as PegIntron and Basel, Switzerland-based Roche Holding AG (ROG) as Pegasys. The FDA approved PegIntron in 2001 and Pegasys in 2002.

Boceprevir and telaprevir are so-called protease inhibitors that work by blocking an enzyme used by the hepatitis C virus to copy itself.

The FDA agreed to evaluate both drugs under a six-month priority-review program reserved for therapies that may provide major advances. The agency typically takes at least 10 months to rule on drug applications that aren’t granted priority status.

Separate clinical trials on boceprevir and telaprevir showed both drugs cured more patients in less time when used with approved treatments. There haven’t been clinical studies that compare whether one drug is more effective than the other.

Both drugs also are under review by the European Medicines Agency. Telaprevir would be marketed in Europe by Vertex and New Brunswick, New Jersey-based Johnson & Johnson (JNJ), the world’s second-biggest seller of health products.

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