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Home Industry News Bristol-Myers Squibb receives EU approval for hepatitis C drug

Bristol-Myers Squibb receives EU approval for hepatitis C drug

28th August 2014

Bristol-Myers Squibb has announced that its new hepatitis C drug Daklinza has been approved by the European Commission.

The potent pan-genotypic NS5A replication complex inhibitor has been ratified for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus infections in adults.

When used in combination with sofosbuvir, this all-oral interferon-free regimen has been shown to provide cure rates of up to 100 percent in clinical trials, including among patients with advanced liver disease and those who have previously failed treatment with protease inhibitors.

The company hopes the launch of the medicine will help to maintain recent progress towards the eventual goal of eradicating the disease completely.

Emmanuel Blin, head of worldwide commercialisation at Bristol-Myers Squibb, said: "We look forward to our continued work with EU health authorities to ensure Daklinza-based regimens are available to patients as quickly as possible."

The drug has been approved following an accelerated review process in Europe, which acknowledged the product's potential to address a crucial unmet need.ADNFCR-8000103-ID-801744978-ADNFCR

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