Posts tagged ‘Optimer’

DIFICID (fidaxomicin) Advisory Committee

On Tuesday April 5, 2011 the FDA’s AntiInfective Advisory Committee will discuss Optimer Pharmaceutical’s (OPTR) drug DIFICID (fidaxomicin) for the treatment of adult Clostridium difficile.  The sponsor seems to have conducted adequate studies demonstrating that the disease and the organism are both present at the start of the study and the disease and organism are not present after treatment.  The FDA Briefing Document seems to pose no threat to the approval of this drug.  The company has shown that the drug is both safe and effective in the indicated population.  While the FDA reviewer took issue with some of the outcomes, the conclusion is identical to that of the sponsor.

There are really only 2 issues which will warrant discussion.  The first is the second question posed to the Advisory Committee related to recurrence.  If this question is intended to provoke a discussion on resistance, the result can only be – the bug will eventually win.  Bacteria have always found a way to become resistant and they always will.

The second discussion topic might be the non-inferiority analysis.  I think this will be academic, brief and in favor of the sponsor.