Actavis` Generic Fidaxomicin Receives Approval in the U.S.
RHEINFELDEN, Switzerland--(BUSINESS WIRE)--Tillotts Pharma AG (“Tillotts”), part of the Japanese Zeria Group, welcomes the recommendation that DIFICLIRTM (fidaxomicin) should be used for the initial treatment and first recurrence of Clostridioides difficile infection (CDI) in updated guidance from the European Society of Clinical Microbiology and Infectious Diseases (ESCMID).1 ESCMID guidance is now consistent with the Infectious Disease Society of America (IDSA) guidelines which also recommend fidaxomicin for initial and recurrent episodes of CDI.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Seres Therapeutics, Inc. (Nasdaq: MCRB) today announced the presentation of previously announced positive Phase 3 results from the ECOSPOR III trial of SER-109 at the Virtual American College of Gastroenterology (ACG) Annual Scientific Meeting taking place October 23-28, 2020. New data to be presented in Seres’ late-breaker oral presentation show that SER-109 led to a sustained highly statistically significant absolute reduction in C. difficile infection recurrence at 12 weeks post-treatment when compared to placebo. Additionally, new findings demonstrate that SER-109 administration resulted in similar efficacy when stratified by age groups (i.e., > or <65 years) or prior antibiotic received (i.e., vancomycin or fidaxomicin).
Tokyo, July 31, 2017 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) today announced that it has submitted an application for marketing approval of fidaxomicin (generic name) for the treatment of infectious enteritis (including pseudomembranous colitis1) (susceptible strains: fidaxomicin susceptible Clostridium difficile2).
The positive verdict comes after the FDA asked for additional information to enable their review of Zinplava (bezlotoxumab; MK 6072), delaying its approval by three months. In June, an FDA advisory committee voted by 10 to 5 with one abstention that Zinplava (bezlotoxumab) is effective for preventing the recurrence of C. difficile infections.