Bristol-Myers Squibb Co. said its experimental hepatitis C
treatment combined with an older drug, ribavirin, and Gilead
Sciences Inc.'s Sovaldi cured more than 90% of patients with liver
transplants and cirrhosis in a late-stage study.
"Post-liver transplant and cirrhotic patients represent a
still-unmet need and continue to present challenges to currently
available regimens, " Douglas Manion, Bristol's head of specialty
development, said in a news release Monday.
The data, presented at the International Liver Congress, showed
94% of patients that had hepatitis C following a transplant were
cured after 12 weeks of treatment, as well as 83% of patients with
advanced cirrhosis.
No serious adverse events were reported in the study.
Bristol has been focusing on the hepatitis C treatment--called
daclatasvir--in combination with Sovaldi following the U.S. Food
and Drug Administration's r ejection of its new drug application in
November for daclatasvir in combination with asunaprevir.
Bristol-Myers in October had withdrawn asunaprevir as commercial
prospects for the treatment had dimmed based on progress by Gilead
and AbbVie Inc.
The FDA in its response letter last year requested additional
data about daclatasvir in combination with other antiviral
agents.
Daclatasvir in combination with other drugs received approval by
European regulators last year. It also has received approvals in
Japan and a number of other countries. The FDA is reviewing
Bristol's new drug application for daclatasvir and Sovaldi to treat
patients with hepatitis C genotype 3.
Bristol shares rose 1.2% to $66.56 in recent premarket
trading.
Write to Tess Stynes at tess.stynes@wsj.com
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