Bristol-Myers is gearing to establish itself as a
leading player in the hepatitis C market and, as of now, has substantial
data to convince the market likewise; the company, however, faces stiff
competition from Gilead Sciences, which dominates the market with its
blockbuster drugs Sovaldi and Harvoni
Bristol-Myers Squibb Co (BMY)
said Saturday that its experimental all-oral hepatitis C drug
daclatasvir, when used in conjunction with asunaprevir (ASV) and
beclabuvir (BCV), proved to achieve a 98% cure rate in treatment-naive
and 93% cure rate in treatment-experienced genotype 1 patients of
hepatitis C virus, when administered along with ribavirin, in the
company’s Phase 3 UNITY trials.
Results from the UNITY trials came after the company announced in
October that it is scrapping plans to secure approval for the use of ASV
in conjunction with daclatasvir in treating hepatitis C patients. This
announcement was made despite the fact that the combination had won
approval in Japan earlier during the year. Bristol-Myers said that the
dual treatment regimen was developed solely to meet the distinct needs
of the Japanese patient population.
Bristol-Myers
indicated last month that the company will continue to work toward
obtaining the US Food and Drug Administration’s (FDA) approval for the
use of daclatasvir in treating hepatitis C, when administered in
conjunction with other agents being developed by the company. Now, the
data from the company’s UNITY trials, which are part of an
investigational study being conducted by the company, indicate that
Bristol-Myers’ experimental drug, when used in combination with ASV and
BCV, yield statistically viable results for treating hepatitis C.
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Labels: BMS, daclatasvir+ asunaprevir (ASV) and beclabuvir (BCV), GT1, UNITY Trial