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Pharmaceuticals / Submissions and Approvals

MHRA Grants Early Access to AbbVie’s Hepatitis C Combo Treatment

May 17, 2017
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The U.K.’s Medicines and Healthcare products Regulatory Agency granted early patient access to AbbVie’s glecaprevir/pibrentasvir combination treatment for chronic hepatitis C, ahead of European Union approval.

The combination is currently undergoing expedited review at the European Medicines Agency for all genotypes. The EMA’s Committee for Medicinal Products for Human Use will also review the regimen. AbbVie submitted an application to FDA in December 2016.

The MHRA said the oral tablet combination was granted early access because it was shown to be highly effective in clearing the virus from the bloodstream in patients with compensated cirrhosis. Clearance was also observed in patients who had previously failed treatment with NS5A inhibitors, the agency said.

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