Not only was the recovery time faster among those who took fidaxomicin, but nearly 75 percent recovered without a recurrence, compared to 64.1 percent for the vancomycin patients. ❋ Unknown (2011)
In two Phase 3 trials for the treatment of CDI, fidaxomicin was equally effective in clinical cure when compared to vancomycin, the only FDA approved product for CDI. ❋ Unknown (2011)
The new drug, known generically as fidaxomicin, is only the third antibiotic cleared by the FDA since 2006, according to Optimer. ❋ Unknown (2011)
In a trial involving more than 600 patients, fidaxomicin was as effective as the existing treatment in fighting the gut-wrenching infection, but fewer patients had a recurrence. ❋ ANNE-MARIE TOBIN (2011)
The issuance of this patent is part of our intellectual property strategy to protect fidaxomicin in all methods and dosages for treating patients with ❋ Unknown (2011)
The newly issued patent and a previously issued patent encompassing fidaxomicin are both orange book listable. ❋ Unknown (2011)
"It's virtually impossible to beat vancomycin as a cure, but using fidaxomicin we could beat it with recurrence," said Gorbach, professor of medicine, immunology, molecular biology and microbiology at Tufts University School of Medicine in Boston. ❋ Unknown (2011)
Optimer has developed and is commercializing DIFICID™ fidaxomicin tablets, an FDA-approved antibacterial drug for the treatment of adult patients with
Patent 7,863,249 which covers additional dosage forms of fidaxomicin. ❋ Unknown (2011)
Also during the quarter, the company announced the signing of an exclusive two-year co-promotion agreement with Optimer Pharmaceuticals to market DIFICID™ fidaxomicin tablets, in the United States.
The study found that fidaxomicin was just as good as vancomycin in eliminating C. difficile at the end of 10 days of treatment - but there was a 45 per cent reduction in recurrences of infection with the new drug. ❋ ANNE-MARIE TOBIN (2011)
Most importantly, fidaxomicin was statistically superior to vancomycin in global cure and in reducing recurrences of CDI by up to 47%. ❋ Unknown (2011)
Optimer has two anti-infective product candidates in development, fidaxomicin and Pruvel™ prulifloxacin. ❋ Unknown (2011)
"In places that don't have a lot of NAP1, this study suggests that fidaxomicin would be better." ❋ ANNE-MARIE TOBIN (2011)
Optimer has filed marketing applications in the U.S. and the EU for fidaxomicin for the treatment of CDI and for the prevention of recurrences. ❋ Unknown (2011)
Optimer has filed a marketing authorization application with the European Medicines Agency for fidaxomicin.
The drug called DIFICLIR, or fidaxomicin, was approved for use in the U.S. by the FDA in May.
This patent further strengthens Optimer's patent protection for fidaxomicin. ❋ Unknown (2011)
The Phase 3 trial of fidaxomicin, the first in a new class of narrow-spectrum macrocyclic antibiotics, compared it to the current treatment vancomycin at 52 sites in the United States and 15 sites in Canada. ❋ ANNE-MARIE TOBIN (2011)
