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Simeprevir Approved in the European Union

Fri, 05/16/2014 - 8:29am

Medivir AB has announced that simeprevir has been granted marketing authorization by the European Commission (EC) for the treatment of adults with genotype 1 and 4 chronic hepatitis C in combination with other medicinal products.

"The approval of simeprevir in Europe is a further step in our partner's global strategy to enable an improved treatment for hepatitis C patients. This also means that Medivir will now be able to offer this treatment to patients in the Nordic region, where we have the marketing rights", says Maris Hartmanis, CEO, Medivir.

This marketing authorization represents a significant milestone in the development of new triple therapy hepatitis C (HCV) treatment options for genotype 1 and 4 patients. It also includes simeprevir as part of an all oral 12-week interferon-free direct-acting antiviral (DAA) regimen with or without ribavirin (RBV), in genotype 1 or 4 patients, who are intolerant to or ineligible for IFN treatment.

The EC approval for simeprevir with PegIFN + RBV is based on a clinical trial programme involving three pivotal phase III studies, with over 1000 patients. The trials; QUEST-1, QUEST-2 and PROMISE, explored the use of simeprevir in combination with PegIFN/RBV in treatment-naïve patients and patients who have relapsed after prior interferon-base treatment. All three studies met their primary endpoints and demonstrated that simeprevir in combination with PegIFN/RBV, achieves significant cure rates when compared with PegIFN/RBV alone.

The EC approval for the combination of simeprevir and sofosbuvir also contains the phase II study, COSMOS. This was based upon prior null responder and treatment-naive patients.

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