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FDA and UK’s NICE Offer Guidance on UTIs and Developing New Treatments

Posted 09 May 2018 | By Zachary Brennan 

FDA and UK’s NICE Offer Guidance on UTIs and Developing New Treatments

The US Food and Drug Administration (FDA) on Wednesday released draft guidance for sponsors to help develop antibacterial drugs for women with uncomplicated urinary tract infections (UTIs).

The draft focuses on efficacy and safety considerations, including primary efficacy endpoints, as well as pharmacokinetic and dose selection considerations.

As far as specific efficacy trial considerations, FDA said sponsors should conduct randomized, double-blind, controlled trials in female patients with uncomplicated UTIs, as opposed to complicated UTIs (which FDA has separate guidance for) using a superiority or noninferiority design.

Also on Wednesday, the UK’s NICE unveiled new guidance to help health professionals optimize the treatment of UTIs.

Susan Hopkins, deputy director at Public Health England, said: “Our surveillance shows that more than a third of laboratory confirmed E.coli UTIs display resistance to key antibiotics. We are therefore urging GP practices and hospitals to follow the new guidelines so they can prescribe antibiotics appropriately to their patients.  This will preserve our antibiotics so that they not only save lives today but can continue to save lives tomorrow.”

The consultation on the NICE guidelines close on 5 June 2018.


Categories: Regulatory News

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