Optimer/Astellas CDI receives positive opinion from EMA committee

Optimer Pharmaceuticals has announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for DIFICLIR tablets for the treatment of adults suffering with a Clostridium difficile infection (CDI), also known as C. difficile-associated diarrhea. DIFICLIR was approved by the FDA in May 2011 for the treatment of CDAD in adults 18 years of age and older. Astellas is Optimer’s exclusive licensee to develop and commercialize DIFICLIR in Europe and ther countries. The European Commission generally follows the recommendations of the CHMP and delivers its final decision within three months of the CHMP opinion.