EC grants marketing authorisation to Dificlir

Published: 12-Dec-2011

For the treatment of adults with Clostridium difficile infections

The European Commission has granted marketing authorisation for Dificlir (fidaxomicin) tablets for the treatment of adults with Clostridium difficile infections (CDI). CDI is a significant problem in hospitals and long-term care facilities all over the world.

The approval was based on two multi-national Phase III clinical trials, which demonstrated that Dificlir is as effective as oral vancomycin in treating CDI. Dificlir had a significantly lower rate of recurrence (including relapses) compared with vancomycin in the 30 days following treatment. Dificlir is the only drug approved by the EMA that is proven significantly to lower the rate of recurrence of CDI compared with oral vancomycin. The clinical trials included patients over the age of 65 and those taking concomitant antibiotics to treat multiple infections.

Optimer Pharmaceuticals, based in San Diego, California in the US, is the developer of the drug.

‘The European approval is a key step in making fidaxomicin more widely available to patients across the globe to treat this very serious disease,’ said Pedro Lichtinger, president and chief executive of Optimer.

The European approval affirms the recent positive opinion from the Committee of Medicinal Products for Human Use (CHMP).

Astellas Pharma Europe, a European subsidiary of Japanese pharmaceutical firm, Astellas Pharma, is Optimer's exclusive licensee to develop and market Dificlir in Europe and additional countries in the Middle East, Africa and the Commonwealth of Independent States.

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