The CHMP has recommended Astellas Pharma and Optimer Pharmaceuticals’ Dificlir (fidaxomicin) to treat adults with colon disease.
The drug specifically targets the bacteria causing the infection in the colon whilst avoiding ‘friendly’ bacteria in the gut of patients with the disease, which is also known as Clostridium difficile-associated diarrhoea (CDAD).
Ken Jones, President and CEO of Astellas Pharma Europe, said: “European patients with this potentially fatal disease can take encouragement from the positive CHMP opinion for Dificlir that a new medication for clostridium difficile infection may soon be available.”
Dificlir’s active substance is fidaxomicin, which belongs to the macrocyclic class of antibacterials and inhibits RNA synthesis by bacterial RNA polymerase.
Dr Xavier Luria, Head of Safety and Efficacy at the EMA, said: “This is a promising step forward in the Agency’s drive for addressing patients’ needs in infectious diseases.”
The positive opinion is based on Phase III clinical research data comparing fidaxomicin with oral vancomycin on patients in the US and Canada. Results of the studies showed that clinical cure was achieved at the end of ten days of treatment with both treatments. Furthermore, fidaxomicin had a significantly lower rate of recurrence of CDI compared to vancomycin.
Dificlir, known as Dificid in the US, was approved by the FDA in May for the treatment of CDAD in adults.
The European Commission will deliver its final decision within three months.
CDI is a serious illness resulting from infection of the internal lining of the colon by C. difficile bacteria. The bacteria produce toxins that cause inflammation of the colon, diarrhoea and, in some cases, death.
UK-based Astellas Pharma Europe manufactures and distributes pharmaceuticals globally with the intention to improve lives through the introduction of innovative and reliable pharmaceutical products.
Optimer Pharmaceuticals, is a biopharmaceutical company focused on developing and commercialising hospital specialty products to treat serious infections and address unmet medical needs.