Optimer Pharmaceuticals, Inc has submitted a Marketing Authorization Application (MAA) for fidaxomicin to the European Medicines Agency (EMA) under the European Union's Centralized Procedure. Optimer is seeking approval to market fidaxomicin for the treatment of patients with Clostridium difficile infection (CDI).
"The submission of our fidaxomicin MAA represents a significant step in making this innovative medicine available to European patients and to join the many on-going efforts to improve health care cost in the EU. Clostridium difficile infection is a growing disease and major unmet medical need. We are excited with the opportunity it represents for our company. Europe is an important market opportunity for us as the increased awareness of CDI over the past several years has led to improved diagnosis and reporting of the disease," said Pedro Lichtinger, president and CEO of Optimer. "As more resources are committed to understanding CDI in Europe, its prevalence and the importance of treating this disease in this market will be better appreciated. This MAA is the next step towards making fidaxomicin part of the solution to what appears to be an expanding clinical problem in the European market."
Optimer also plans to submit a new drug application to the US FDA in 2010 for marketing approval of fidaxomicin in the US.
Fidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in the death of C. difficile.
CDI has become a significant medical problem in hospitals, long-term care facilities, and in the community. It is a serious illness caused by infection of the inner lining of the colon by C. difficile bacteria, which produces toxins that cause inflammation of the colon, severe diarrhoea and, in the community. It is a serious illness caused by infection of the inner lining of the colon by C. difficile bacteria, which produces toxins that cause inflammation of the colon, severe diarrhoea and, in the most serious cases, death.