More news from EMA/CHMP September meeting

Following its meetings last week, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a batch of recommendations, some of which (such as those on Multaq, Xarelto, Komboglyze and Levemir) were reported by The Pharma Letter over the past two days.

Adding to the list, the CHMP has recommended the authorization of the first antibiotic in a new class to treat infections with Clostridium difficile, Japanese drug major Astellas’ (TYO: 4503) Dificlir/Dificid (fidaxomicin), a first-in-class macrocyclic antibiotic, promises to improve current treatment of the inflammation of the gut and severe diarrhea caused by C. difficile.

Novel antibacterial agents are needed to overcome the harmful consequences of bacterial resistance. The CHMP’s opinion therefore represents a major step forward by providing a new medicine to tackle the growing levels of resistance to available antibiotics across the European Union, the EMA stated.