FDA approves Merck's new hepatitis C pill

[January 29, 2016]  By Deena Beasley

(Reuters) - U.S. regulators on Thursday approved a new once-daily pill for the liver-destroying hepatitis C virus made by Merck & Co Inc, which said it will sell the drug at a lower list price than its competitors.

The list price for Zepatier will be $54,600 for a 12-week regimen, which Merck said it expects "to be in the range of net prices" for comparable treatments.

Gilead Sciences Inc, which secured an early lead in the lucrative market for oral hepatitis C drugs with the $1,000-per-pill Sovaldi, currently sells an enhanced version of that drug as a single-tablet regimen called Harvoni at a list price of $94,500. AbbVie Inc followed in late 2014 with a multi-pill regimen. Nevertheless, AbbVie secured exclusive contracts with payers such as pharmacy benefit manager Express Scripts Holding Co, forcing Gilead to discount its own contract prices.

Gilead has continued to dominate the market with hepatitis C drug sales of more than $14 billion in the first nine months of 2015.

The Food and Drug Administration approved Zepatier, with or without the older antiviral drug ribavirin, for patients infected with the most common form of hepatitis C, genotype 1, as well as the less common genotype 4.

The new drug's FDA label says liver-related blood tests should be performed prior to starting therapy and at certain times during treatment.

Clinical trials found that 12 or 16 weeks of treatment with Merck's Zepatier reduced the virus to undetectable levels, which is considered a cure, in more than 94 percent of patients, the FDA said in a statement.

Hepatitis C infects an estimated 3.2 million Americans.

(Reporting by Deena Beasley; Editing by Leslie Adler, Bernard Orr)

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