Among the 35 new molecular entities approved by the FDA in 2011, 17 were particularly notable for their significant contributions to the health of patients, including
abiraterone acetate,
vandetanib,
belatacept and
fidaxomicin. Thus,
abiraterone acetate, namely Zytiga®, was included as the first in a new class of drugs to treat late-stage
prostate cancer. The ability of Zytiga® to prolong survival in these patients was considered as significant because they have few other treatments options and the benefits of Zytiga® outweighed the risks of reported side-effects.
Vandetanib, namely Caprelsa®, was also considered as a relevant
drug since it represents the first
drug approved to treat particularly aggressive
medullary thyroid cancer, an
orphan disease. Despite huge progress in
transplantation, renal transplantation remains a serious problem since patients treated with the
calcineurin inhibitors cyclosporine and
tacrolimus are at high risk of developing renal injury. With longer follow-up, the novel
immunosuppressant belatacept continued to show better renal function compared with a
cyclosporine-based regimen, as well as a consistent safety profile and comparable efficacy. It was approved by the Food and Drug Administration in June 2011 for the prophylaxis of organ rejection in adult recipients of a kidney transplant acting by a selective T-cell costimulation blocker given as an infusion. Clostridium difficile is currently the most important cause of infectious
diarrhea in the United States.
Fidaxomicin, a
macrolide antibiotic, was recently approved for treatment of these
infections (CDIs). It could be an alternative treatment for
infection with C. difficile, with similar efficacy and safety to
vancomycin.
Fidaxomicin has minimal activity against Bacteroides species, which may be advantageous in maintaining colonization resistance and protecting the gastrointestinal tract from colonization by C. difficile.