Optimer Pharmaceuticals Inc. and Astellas Pharma Europe Ltd. said Friday that a European agency had adopted a "positive opinion" of its drug for colon disease, which could pave the way for its use in the European Union.
The drug called DIFICLIR, or fidaxomicin, was approved for use in the U.S. by the FDA in May.
Optimer said the Committee for Medicinal Products for Human Use, a division of the European Medicines Agency, had recommended DIFICLIR for use in the European Union. Optimer said the EU usually follows the committee's recommendations.
The drug is meant to treat CDI, or Clostridium difficile, a bacterial infection of the colon.
Optimer, based in San Diego, and Astellas Pharma Europe Ltd., a subsidiary of Tokyo-based Astellas Pharma Inc., worked on the drug.
Optimer's shares swung wildly Friday. They climbed to a 52-week high of $17.95 in the morning. They fell back in the afternoon to $15.96, down 91 cents or 5.4 percent.
