Astellas and partner Optimer
Pharmaceuticals are celebrating after regulators in Europe gave the green light
to their antibiotic Dificlir.
The European Commission has
approved Dificlir (fidaxomicin) for the treatment of Clostridium difficile
infections, which can cause severe diarrhoea. The thumbs-up is based on two
Phase III trials which compared the drug with oral vancomycin, a common
antibiotic used to treat CDI.
The data showed that Dificlir
was as effective as vancomycin in treating CDI and had a significantly lower
rate of recurrence (including relapses) compared to vancomycin in the 30 days
following treatment. Some 1,1164 patients were involved in the studies.
The first-in-class macrocyclic
antibiotic was approved in the USA in May, where it is sold as Dificid and has
got off to a reasonable start. It posted sales of $10.6 million for its first
quarter on the market across the Atlantic.
Pedro Lichtinger, Optimer's
chief executive, said 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 that "we believe we have obtained a
very strong label recognising the benefits of Dificlir".
The approval was expected,
given that European Medicines Agency's Committee for Medicinal Products
for Human Use recommended its authorisation in September. Then, the EMA noted
that the potential cost of C 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 drugmaker paid an
upfront fee of $68 million and the alliance could be worth over $220 million to
Optimer.
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