Dificlir Gains European Approval
Astellas and partner Optimer Pharmaceuticals announced yesterday that regulators in Europe have given the green light to their antibiotic Dificlir.
The European Commission has approved Dificlir (fidaxomicin) for the treatment of Clostridium Difficile infections (CDI) in adults, which can cause severe diarrhoea. The approval is based on two Phase III trials which compared Dificlir with oral vancomycin, a common antibiotic used to treat CDI.
Clostridium Difficile infection has become a significant issue in hospitals, long-term care facilities and in the community. CDI is a severe illness resulting from infection of the inner lining of the colon by Clostridium Difficile bacteria, which produces toxins that cause inflammation of the colon, severe diarrhoea and, in the most severe cases, death. Roughly two-thirds of patients are 65 years of age or older. Historically, around 20% to 30% of CDI patients who initially respond to treatment experience a clinical recurrence.
The studies demonstrated that Dificlir was as effective as vancomycin in treating the infection and had a significantly lower rate of recurrence (including relapses) in the 30 days succeeding treatment. The clinical trials included patients over the age of 65 and those taking concomitant antibiotics to treat multiple infections. 1,164 patients were involved in the trials.
The two Phase 3 clinical trials were conducted to ensure the safety and efficacy of 400mg/day Dificlir compared to 500mg/day oral vancomycin for 10 days in subjects with CDI. The first Phase 3 study was carried out in North America (US and Canada). The second Phase 3 study was carried out in North America and Europe. 47.9% of the people enrolled in the studies were 65 years or older and 27.5% were treated with concomitant antibiotics.
The first-in-class macrocyclic antibiotic was approved in the USA in May, and posted sales of $10.6 million for its first quarter.
Pedro Lichtinger, Optimer’s chief executive, commented that the “European approval is a key step in making fidaxomicin more widely available to patients across the globe to treat this very serious disease”. He added “we believe we have obtained a very strong label recognising the benefits of Dificlir”.
The approval was expected, given that European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use recommended its authorisation in September. Then, the EMA noted that the potential cost of Clostridium Difficile infection per year in the European Union has been estimated to be as high as 3 billion euros.
Astellas bagged the rights to Dificlir in Europe, the Middle East, Africa and the Commonwealth of Independent States in a deal signed in February this year. The Japanese drug maker paid an upfront fee of $68 million and the alliance could be worth over $220 million to Optimer.