FDA Approves Merck's New Hepatitis C Treatment
January 28 2016 - 7:10PM
Dow Jones News
The U.S. Food and Drug Administration approved Merck & Co.'s
new treatment for hepatitis C, the latest entrant in a booming
market for drugs for the viral infection—a market now dominated by
Gilead Sciences Inc.
Merck's treatment, Zepatier, is a once-daily, single-tablet
combination of two drugs, grazoprevir and elbasvir. It is approved
for patients infected with the most common type of hepatitis C in
the U.S., known as genotype 1, and a less common type, genotype
4.
Merck's treatment will compete with expensive drugs from Gilead
and AbbVie Inc.
Gilead's Sovaldi and Harvoni had combined sales of $14.2 billion
for the first nine months of 2015, helped by high price tags—about
$84,000 for a typical course of Sovaldi and $94,500 for
Harvoni.
AbbVie was the first to challenge Gilead by launching of Viekira
Pak in late 2014. But it hasn't taken much of Gilead's market
share; Viekira sales were $1.1 billion for the first nine months of
2015. Viekira costs about $83,000 a patient for a standard
course.
Merck didn't immediately release the price of Zepatier on
Thursday.
Bernstein analyst Tim Anderson estimates Merck can capture an
11% share of the hepatitis C market in 2017 with its new product,
which would amount to about $2.2 billion in sales.
Clinical studies showed that 12 or 16 weeks of treatment with
Merck's therapy reduced the virus to undetectable levels, which
doctors say amounts to a cure, in more than 94% of patients, the
FDA said in a news release Thursday.
An estimated 3.5 million Americans have chronic hepatitis C
infection, according to the U.S. Centers for Disease Control and
Prevention. The virus is spread through contact with the blood of
an infected person, including by sharing needles. If left untreated
it can lead to serious liver disease over time.
Merck also is developing a triple-drug combination that could be
used to treat additional subtypes of hepatitis C, potentially in
shorter durations. That could hit the market in 2018, Bernstein
estimates.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
January 28, 2016 18:55 ET (23:55 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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