New antibiotics guidance
The US Food and Drug Administration (FDA) released draft guidance on noninferiority testing for antibiotic drugs in acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and acute bacterial otitis media. The agency suggested that companies will have to amend ongoing or completed trials that aim to show noninferi-ority, because accrued data in those areas have not established the efficacy of active treatment compared to placebo. That means companies should reevaluate even those trials linked to a special protocol assessment (SPA), as “the state of the science has changed” and those trials might no longer be appropriate to support approval, the document says. Mostly at issue are drugs that are cleared through comparison to previous drugs approved with noninferiority endpoints; the concern is that multiple generations of drugs have been cleared in this fashion. The agency recommends considering other ways of proving effectiveness in those three indications and advises comparing time for clinical improvement in addition to overall cure rates. The FDA plans to publish more guidance on the use of noninferiority trials in all therapeutic areas, and according to Helen Boucher of Tufts New England Medical Center and the Infectious Diseases Society of America (IDSA), there is worry this could lead to a chilling effect for the industry given that the approval bar is getting higher. Boucher says IDSA has concerns about “the feasibi-lity and ethics” of doing placebo-controlled trials, but also says dose-ranging superiority studies may provide adequate answers. The FDA and IDSA are in discussions to hold a workshop in the coming months to focus on questions concerning study design. AL
This is a preview of subscription content, access via your institution