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EC approves first-in-class antibiotic Dificlir

Astellas' treatment for Clostridium difficile infection granted marketing authorisation in the EU

The European Commission (EC) has approved Dificlir, a new first-in-class antibiotic developed by Astellas and partner Optimer Pharmaceuticals, as a treatment for a serious diarrhoeal illness with limited treatment options.

Dificlir (fidaxomicin) - the first antibiotic in the macrocyclic class to reach the market - has been cleared in the EU for the treatment of Clostridium difficile infections (CDI) based on two phase III trials which compared the drug with oral vancomycin, an antibiotic commonly used to treat the disease.

While patients with CDI generally have a response to vancomycin or another antibiotic called metronidazole, recurrence of infection occurs within two months for up to a third of patients, and additional treatment options are needed.

Moreover, the clinical profile of CDI has worsened considerably in the last 10 years, with rising numbers of cases, particularly among the elderly, and patients generally sicker and with a higher risk of dying from the infection. There are also concerns that resistance could emerge to vancomycin, currently a last-line option in CDI and other serious infections.

EU approval has been granted on the back of phase III studies which showed that Dificlir was at least as effective as vancomycin in treating CDI but had a significantly lower rate of recurrence (including relapses) in the 30 days following treatment.

The drug is thought to exert greater activity against C. difficile than vancomycin because it is bactericidal - in other words it kills bacteria - rather than bacteriostatic (blocking bacterial growth). It also targets C. difficile specifically, so its effect on other, beneficial bacteria in the gut is minimal, reducing side effects. The new mode of action also reduces the chances that its activity will be affected by resistance to other antibiotics.

Fidaxomicin was approved in the US earlier this year where it is sold as Dificid. US sales were a little over $10m in its first quarter on the market. Astellas has rights to the drug in Europe, the Middle East and Commonwealth of Independent States under the terms of a $288m agreement signed with Optimer earlier this year.

Optimer's chief executive Pedro Lichtinger said the European approval includes "a very strong label recognising the benefits of Dificlir versus vancomycin, including significant reductions in recurrence."

The European Medicines Agency (EMA) estimates that the potential cost of CDI per year in the EU is around €3bn, and the organism is now one of the leading causes of hospital-acquired disease.

13th December 2011

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