China Approves Bristol-Myers Squibb's Dual-Drug Hepatitis C Treatment
April 28 2017 - 8:51AM
Dow Jones News
BEIJING--China's drug regulator approved Bristol-Myers Squibb
Co.'s all-oral treatment for hepatitis C, which will be the first
therapy of its kind for the liver disease to be sold in the
country, giving the U.S. company a leg up in the Chinese
market.
Friday's decision by the China Food and Drug Administration
means the estimated 10 million Chinese infected with hepatitis C
will be able to gain access to a treatment that has been available
in other markets, including Japan, for several years. Chinese
patients have mainly relied on older treatments for hepatitis C,
which typically involve painful injections of drugs that often
produce severe side effects such as headaches and hair loss.
Bristol-Myers's treatment combines two antiviral drugs,
daclatasvir and asunaprevir. In its decision, the agency said the
combination was approved for treating a type of hepatitis C known
as genotype 1b, the most prevalent in China. The regulator also
approved daclatasvir for use in combination with other drugs to
treat more types of the disease.
The dual regimen was first approved for use in Japan in 2014. I
t wasn't marketed in the U.S., however, because Bristol-Myers later
that year withdrew its FDA application for asunaprevir as competing
drugs were nearing approval. Daclatasvir was approved by the FDA
for use in a combined therapy with U.S.-based Gilead Sciences
Inc.'s blockbuster drug Sovaldi to treat hepatitis C.
China's drug regulator is trying to accelerate its review
process for innovative medicines with huge clinical demand. In the
past few months, a number of imported drugs have been approved for
the Chinese market, including AstraZeneca PLC's lung cancer drug
Tagrisso and Novartis AG's Votrient for kidney cancer.
Approval for Bristol-Myers's hepatitis C treatment likely
presages fierce competition with other drugmakers for a share of
the Chinese market. Gilead, Johnson & Johnson unit Janssen
Pharmaceuticals Inc. and domestic startup Ascletis Pharmaceuticals
have products that are nearing approval, according to drug
administration records.
New York-based Bristol-Myers hasn't disclosed pricing for the
newly approved drugs, but a company representative said Friday it
would depend on how quickly the drugs gain approval for inclusion
in reimbursement programs at the national and provincial levels.
The wholesale acquisition cost--the price paid by hospitals and
other large purchasers--for a 12-week course of treatment for
daclatasvir is $63,000, according to Hepatitis C Online, a site
maintained by the University of Washington. A combined regimen
would cost more.
A high price tag is likely to be prohibitive in China. The
country's regulators are giving foreign drugmakers greater access
to the domestic market in hopes that competition will help bring
prices down. Hepatitis C is more common in rural areas and small
cities where incomes are typically lower. Some Chinese patients
have traveled overseas to obtain less expensive versions of
treatments for the disease.
Fanfan Wang
(END) Dow Jones Newswires
April 28, 2017 08:36 ET (12:36 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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